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Last Updated: January 18, 2020

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CLINICAL TRIALS PROFILE FOR COLD CAPSULE V

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

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Cold Capsule V

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cold Capsule V

Condition Name

Condition Name for Cold Capsule V
Intervention Trials
Healthy 240
Healthy Volunteers 66
HIV Infections 46
Pulmonary Disease, Chronic Obstructive 31
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Condition MeSH

Condition MeSH for Cold Capsule V
Intervention Trials
HIV Infections 52
Pulmonary Disease, Chronic Obstructive 42
Lung Diseases 39
Depression 39
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Clinical Trial Locations for Cold Capsule V

Trials by Country

Trials by Country for Cold Capsule V
Location Trials
China 455
Canada 203
India 96
Spain 82
Australia 78
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Trials by US State

Trials by US State for Cold Capsule V
Location Trials
Texas 236
California 183
Florida 144
New York 142
Pennsylvania 107
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Clinical Trial Progress for Cold Capsule V

Clinical Trial Phase

Clinical Trial Phase for Cold Capsule V
Clinical Trial Phase Trials
Phase 4 260
Phase 3 271
Phase 2/Phase 3 38
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Clinical Trial Status

Clinical Trial Status for Cold Capsule V
Clinical Trial Phase Trials
Completed 980
Recruiting 297
Not yet recruiting 204
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Clinical Trial Sponsors for Cold Capsule V

Sponsor Name

Sponsor Name for Cold Capsule V
Sponsor Trials
Boehringer Ingelheim 90
Pfizer 68
GlaxoSmithKline 57
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Sponsor Type

Sponsor Type for Cold Capsule V
Sponsor Trials
Other 1189
Industry 1176
NIH 121
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