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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR COLD CAPSULE IV


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505(b)(2) Clinical Trials for Cold Capsule Iv

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00009542 ↗ Effects of Kava on the Body's Elimination of Caffeine and Dextromethorphan Completed National Institutes of Health Clinical Center (CC) Phase 4 2001-01-01 This study will examine how kava-a widely used herbal remedy-may affect the body's elimination of other medicines. Many people take kava to reduce anxiety or cause sedation. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between kava and other medications. This study will look at how kava affects the elimination of caffeine-a compound commonly found in chocolate, coffee, tea and soft drinks-and dextromethorphan-an OTC cough suppressant. Normal healthy volunteers 21 years of age or older may be eligible for this 30-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age will have a urine pregnancy test. Study participants will not drink alcoholic beverages or take any medications (except those given in the study) for 2 weeks prior to the study and throughout its duration. In addition, they will abstain from caffeine, grapefruit and grapefruit juice and charbroiled foods for at least 72 hours before and throughout each study day that urine is collected. On day 1 of the study, study subjects will take one dose each of caffeine and dextromethorphan at 4:00 P.M.. They will empty their bladder before the dosing and then collect all their urine after the dosing for the rest of the day and including the next mornings first urine. They will bring the urine samples to the Clinical Center when the collection is complete. This procedure will be repeated 1 week later (study day 8). After the second urine collection is completed, subjects will take 200 milligrams of kava 3 times a day for 21 days. On study day 29 (after 21 days of kava), subjects will repeat the dextromethorphan and caffeine dosing and urine collection described above, while continuing to take kava. Subjects will have an electroencephalograph (EEG) done before starting kava and again at the end of kava (study day 30). For this procedure, several electrodes (metal cups attached to wires) are secured to the scalp with a glue-like substance. A conductive gel fills the space between the electrode and the scalp to ensure good contact. The electrodes will remain in place for about 2 hours and then removed. The subject lies quietly on a bed during the EEG recording. Participation in the study will end with another physical examination and blood tests following the second EEG and urine collection.
New Formulation NCT00055263 ↗ A New Formulation of Calcitriol (DN-101) in Patients With Advanced Malignancies Completed Novacea Phase 1 2002-03-01 The purposes of this study are to: - Test the safety of DN-101 in patients with advanced malignancies - Understand how fast the body absorbs, processes, and eliminates DN-101 - Determine the highest dose of DN-101 that is well tolerated by cancer patients - Learn how fast the body absorbs, processes, and eliminates DN-101 compared to the approved product
New Formulation NCT00498745 ↗ Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects Completed Puma Biotechnology, Inc. Phase 1 2007-07-01 To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a reference capsule and an oral solution in healthy subjects.
New Formulation NCT00499538 ↗ Study Evaluating 3 New Formulations of SKI-606 in Healthy Adult Subjects Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 1 2007-07-01 To evaluate the comparative bioavailability of 3 new tablet formulations of SKI-606 with a reference capsule and an oral solution in healthy subjects.
New Combination NCT00620828 ↗ The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty Completed Pfizer Phase 4 2007-05-01 The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.
New Combination NCT00620828 ↗ The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty Completed Duke University Phase 4 2007-05-01 The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Cold Capsule Iv

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000152 ↗ Randomized Trial of Beta-Carotene and Macular Degeneration Unknown status National Eye Institute (NEI) Phase 3 1982-04-01 To determine whether 50 mg of beta-carotene taken every other day reduces the risk of developing age-related macular degeneration (AMD) among male U.S. physicians who were aged 40 to 84 in 1982. To investigate the possible relationship of AMD with other antioxidants, including selenium and vitamins A, C, and E. To identify potential risk factors for development of AMD. Possible risk factors include height, systemic hypertension, cardiovascular disease, blood cholesterol, cigarette smoking, iris and skin color, sunlight exposure, body mass index, diabetes, and alcohol intake.
NCT00000461 ↗ Harvard Atherosclerosis Reversibility Project (HARP) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1986-12-01 To determine by sequential coronary arteriography whether a lipid-lowering diet with and without lipid-lowering drugs could reverse coronary artery disease in normocholesterolemic patients. Also, to test whether fish oil supplements could improve human coronary atherosclerosis. Finally, to determine the effect of combination therapy with lipid-reducing drugs in patients with coronary heart disease and "normal" cholesterol levels. At least three clinical trials were conducted.
NCT00000500 ↗ Physicians' Health Study Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1981-09-01 To assess the effect on cardiovascular mortality of alternate-day consumption of 325 milligrams of aspirin and, secondarily, the effect on cancer incidence of alternate-day consumption of 50 milligrams of beta-carotene.
NCT00000500 ↗ Physicians' Health Study Completed Brigham and Women's Hospital Phase 3 1981-09-01 To assess the effect on cardiovascular mortality of alternate-day consumption of 325 milligrams of aspirin and, secondarily, the effect on cancer incidence of alternate-day consumption of 50 milligrams of beta-carotene.
NCT00000687 ↗ Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To determine the safety and effectiveness of combining zidovudine (AZT) and interferon alfa-2a (IFN-A2a) in a treatment for Kaposi's sarcoma (KS) in patients who have AIDS. It is hoped with the present study to define the rate at which the treatment affects the tumors and also to assess any toxic effects of the combination treatment over a period of time. In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In addition, it appeared that there was a substantial reduction in KS lesions with this therapy. Potential benefits of this combined therapy include resolution of KS lesions, prolonged survival, a decrease in the frequency and severity of opportunistic infections, improvement in CD4 cells, and a decrease in serum p24 antigens.
NCT00000696 ↗ A Phase I/II Open Label Study To Evaluate the Antiviral Potential of Combination Low-Dose Therapy With Zidovudine and Interferon-Alpha 2A in Patients With Symptomatic HIV Disease Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To evaluate the anti-HIV effect of single agent versus combination therapy with zidovudine (AZT) and interferon alfa-2a (IFN-A2a), as measured by p24 protein expression, viral growth and infectivity in patients with symptomatic HIV disease. To assess the safety of low dose schedules of AZT and IFN-A2a, alone and in combination, as measured by neutrophil counts and hepatic transaminase levels. To evaluate the comparative effects of single agent versus combination therapy with AZT and IFN-A2a on CD4 cell counts and skin test reactivity. AZT is known to be an effective treatment for HIV infection. However, patients may develop reactions to AZT when it is administered for long periods of time. Combining AZT with another drug at lower doses might reduce toxicity in patients and prevent the development of drug resistant strains. IFN-A2a can reduce the growth of HIV in test tube experiments and recent studies have shown that when AZT and IFN-A2a are used together they reduce the growth of HIV more effectively than when either drug is used alone. This study will examine the effectiveness and safety of these drugs when they are given together and compare these results with the effectiveness and safety of the drugs when they are used alone.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cold Capsule Iv

Condition Name

Condition Name for Cold Capsule Iv
Intervention Trials
Healthy 281
Healthy Volunteers 96
HIV Infections 52
Pain 32
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Condition MeSH

Condition MeSH for Cold Capsule Iv
Intervention Trials
HIV Infections 56
Depression 51
Neoplasms 50
Depressive Disorder 49
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Clinical Trial Locations for Cold Capsule Iv

Trials by Country

Trials by Country for Cold Capsule Iv
Location Trials
China 916
Belgium 99
Italy 95
Brazil 81
Netherlands 80
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Trials by US State

Trials by US State for Cold Capsule Iv
Location Trials
Texas 267
California 237
Florida 195
New York 179
Pennsylvania 131
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Clinical Trial Progress for Cold Capsule Iv

Clinical Trial Phase

Clinical Trial Phase for Cold Capsule Iv
Clinical Trial Phase Trials
Phase 4 343
Phase 3 349
Phase 2/Phase 3 56
[disabled in preview] 1319
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Clinical Trial Status

Clinical Trial Status for Cold Capsule Iv
Clinical Trial Phase Trials
Completed 1442
Recruiting 283
Not yet recruiting 225
[disabled in preview] 370
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Clinical Trial Sponsors for Cold Capsule Iv

Sponsor Name

Sponsor Name for Cold Capsule Iv
Sponsor Trials
Boehringer Ingelheim 94
Pfizer 82
GlaxoSmithKline 58
[disabled in preview] 143
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Sponsor Type

Sponsor Type for Cold Capsule Iv
Sponsor Trials
Other 1764
Industry 1628
NIH 152
[disabled in preview] 40
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Clinical Trials, Market Analysis, and Projections for Cold and Flu Treatments: A Comprehensive Overview

Introduction to Cold and Flu Treatments

Cold and flu are among the most common illnesses affecting people worldwide, leading to a significant demand for effective treatments. This article will delve into the latest clinical trials, market analysis, and projections for treatments in this sector, focusing on the broader context of cold and flu drugs rather than a specific product like "Cold Capsule IV," as it is not mentioned in the provided sources.

Clinical Trials Update

Moderna's Vaccine Programs

Moderna is at the forefront of advancing multiple vaccine programs, particularly those targeting viruses that cause latent infections. Here are some key updates:

  • COVID-19 and Flu Combination Vaccine: Moderna is developing a combination vaccine against both COVID-19 and flu, with Phase 3 trials expected to read out in 2024[1].
  • CMV Vaccine: The company's mRNA-1647 vaccine against cytomegalovirus (CMV) is in a pivotal Phase 3 trial, evaluating its efficacy, safety, and immunogenicity in women aged 16 to 40 years. The trial is fully enrolled with approximately 7,300 participants[1].
  • RSV Vaccine: Moderna's mRNA-1345 vaccine against respiratory syncytial virus (RSV) has shown durable efficacy in clinical trials, with a vaccine efficacy of 63.3% against RSV lower respiratory tract disease (LRTD) with two or more symptoms over a longer follow-up period[1].
  • Norovirus Vaccine: The company is advancing its mRNA-1403 norovirus vaccine candidate towards a pivotal Phase 3 trial after showing a robust immune response and acceptable safety profile in Phase 1 trials[1].

Other Significant Clinical Trials

  • Lenacapavir for HIV Prevention: Gilead Sciences' twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, has demonstrated 100% efficacy in preventing HIV infections in cisgender women in the PURPOSE 1 trial. This trial is part of a comprehensive program assessing lenacapavir for pre-exposure prophylaxis (PrEP) in various populations[4].

Market Analysis

Cold and Flu Drugs Market

The global cold and flu drugs market is experiencing significant growth driven by several factors:

  • Market Size and Growth: The market was valued at USD 15.76 billion in 2023 and is expected to grow at a CAGR of 10.86% from 2024 to 2030, reaching nearly USD 32.43 billion by 2030[2].
  • Regional Dynamics: The Asia-Pacific region holds the largest market share, with China being a major contributor due to increasing patient awareness and self-medication practices. Europe follows as the second-largest market, driven by a growing demand for supplements and preventative healthcare[2].
  • Key Players: Pharmaceutical companies such as Cipla, Hetero Drugs, and MacLeod’s Pharmaceuticals in India, and Glenmark Pharmaceuticals and Natco Pharma, are significant players in the market, particularly in the production of antiviral drugs like Oseltamivir[2].

Cold and Flu Supplements Market

The supplements market is also growing rapidly:

  • Market Size and Growth: The global cold and flu supplements market was estimated at USD 15.28 billion in 2022 and is expected to grow at a CAGR of 11.5% from 2023 to 2030[5].
  • Consumer Trends: The increasing awareness among consumers about the healing properties of natural ingredients and the easier availability of supplements both online and in physical stores are driving this growth. Additionally, rising purchasing power globally is leading to higher expenditure on immune health products[5].

Market Projections

Future Growth Drivers

  • Seasonal Variations and Outbreaks: The market for cold and flu drugs and supplements is expected to continue growing due to seasonal variations and outbreaks. The ongoing COVID-19 pandemic has also heightened the demand for these products[2].
  • Increasing Awareness and Self-Medication: Growing awareness among consumers about the benefits of over-the-counter (OTC) medications and supplements will drive market growth. Self-medication practices, especially in regions like the Asia-Pacific, will contribute significantly to this trend[2][5].

Regional Market Projections

  • Asia-Pacific: This region is expected to witness significant growth, driven by the rapid expansion of the Chinese economy and increasing patient awareness. India is also a key market, with pharmaceutical companies experiencing substantial gains in the production of antiviral drugs[2].
  • Europe: The European market, particularly Germany and the UK, will see growth driven by a shift towards preventative healthcare and the use of supplements[2].

Key Takeaways

  • Advancements in Clinical Trials: Moderna and other pharmaceutical companies are making significant strides in developing vaccines against various viruses, including COVID-19, flu, CMV, RSV, and norovirus.
  • Market Growth: The cold and flu drugs and supplements market is expected to grow substantially, driven by seasonal variations, outbreaks, and increasing consumer awareness.
  • Regional Dynamics: The Asia-Pacific region will continue to be a major driver of market growth, followed by Europe.
  • Consumer Trends: The shift towards self-medication and the use of natural supplements will continue to influence market trends.

FAQs

What are the key clinical trials currently underway for cold and flu treatments?

Moderna is advancing several vaccine programs, including a combination COVID-19 and flu vaccine, a CMV vaccine, an RSV vaccine, and a norovirus vaccine. Gilead Sciences is also conducting trials for lenacapavir for HIV prevention.

How large is the global cold and flu drugs market?

The global cold and flu drugs market was valued at USD 15.76 billion in 2023 and is expected to grow to nearly USD 32.43 billion by 2030.

What drives the growth of the cold and flu supplements market?

The growth is driven by increasing consumer awareness of natural ingredients, easier availability of supplements, and rising purchasing power globally.

Which regions are expected to see significant growth in the cold and flu market?

The Asia-Pacific region, particularly China and India, and Europe, especially Germany and the UK, are expected to see significant growth.

What are the most commonly used over-the-counter drugs for cold and flu?

Commonly used OTC drugs include aspirin, acetaminophen, and ibuprofen, which address symptoms like pain, congestion, allergies, and coughing.

How do seasonal variations impact the cold and flu market?

Seasonal variations and outbreaks significantly drive the demand for cold and flu drugs and supplements, contributing to market growth.

Sources

  1. Moderna Advances Multiple Vaccine Programs to Late-Stage Clinical Trials. Moderna, March 27, 2024.
  2. Cold and Flu Drugs Market: Industry Analysis and Forecast (2024-2030). Stellar Market Research, May 20, 2024.
  3. Dupixent approved in the US as the first treatment for inadequately controlled chronic obstructive pulmonary disease (COPD). Sanofi, September 27, 2024.
  4. Gilead’s Twice Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada for HIV Prevention. Gilead Sciences, June 20, 2024.
  5. Cold And Flu Supplements Market Size & Share Report 2030. Grand View Research.

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