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Last Updated: February 26, 2021

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505(b)(2) Clinical Trials for Phenylephrine Hydrochloride

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 NCT01448057 Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu Completed Novartis Phase 3 2013-07-01 The study is a clinical evaluation of an over the counter (OTC) combination product containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10 mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).
New Formulation NCT03339726 Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold Not yet recruiting Johnson & Johnson Consumer Inc. (J&JCI) Phase 2 2017-11-15 This will be a randomized, double-blind, placebo controlled, parallel-group Phase 2 study to evaluate the efficacy of a new formulation of phenylephrine HCl and a currently marketed phenylephrine HCl for relief of nasal congestion in subjects with naturally occurring cold symptoms.
OTC NCT04534452 Study to Find Out Whether Participants With a History of Stuffy Nose Due to Allergic Reactions in the Nose Would Intend to Buy Drug Phenylephrine Hydrochloride Extended Release Tablets After Receiving it Once in This Study Completed Bayer Phase 3 2012-05-12 The researchers in this study want to find out whether participants with a history of stuffy nose due to allergic reactions in the nose would intend to buy drug Phenylephrine Hydrochloride (Phenylephrine HCl) extended release tablet (a pill is formulated so that the drug is released slowly over time) after receiving it once in this study. Phenylephrine HCl is an over-the-counter (OTC) drug (a medicine that can be bought without a prescription) used to provide temporary relief of stuffy nose caused by cold or allergies in mouth, nose and throat. Phenylephrine HCl immediate-release tablet (a pill with drug released rapidly without special rate controlling) was already approved to be used for adults and children and the recommended dose for adults and children 12 years or older is 10mg every 4 hours. Phenylephrine HCl 30mg extended release tablet used in this study is not yet approved but under development with a goal to relieve stuffy nose for every 8 hours. Researchers also want to find out if participants have any medical problems during the trial. Participants in this study will be asked to record their stuffy nose symptoms in a diary before and after drug intake. At 8 hours after drug intake, participants need to assess whether they intends to buy the drug or not and their overall satisfaction of the stuffy nose relief. At the end the participants will complete a questionnaire about their job, learning background, income and medical history of stuffy nose.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Phenylephrine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00011778 PS-341 and Radiation to Treat Advanced Cancer of the Head and Neck Completed National Cancer Institute (NCI) Phase 1 2001-02-01 This study will test the safety and effects of the experimental drug PS-341 plus radiation therapy in patients with head and neck cancer. PS-341 can slow or halt the growth of cancer cells grown in culture or in mice. In addition, the drug appears to enhance the effectiveness of radiation treatment. Patients 18 years of age and older with head and neck cancer that cannot be treated adequately with surgery and cannot be cured with standard radiation and chemotherapy may be eligible for this study. Patients whose cancer has spread to the brain may not participate. Before treatment begins participants are evaluated with CT or MRI scans of the head, neck and chest area to determine the extent of the cancer; an electrocardiogram and blood tests; and a neurocardiovascular evaluation that includes measuring blood pressure in different body positions and involves injections of phenylephrine and nitroglycerine. Some patients may undergo a procedure in which a tube is inserted into the larynx (voice box), bronchi (breathing tubes) and esophagus (food tube) and tissue samples removed. This procedure is done under general anesthesia in the operating room. Patients receive radiation treatments Monday through Friday and injections of PS-341 twice a week during the radiation therapy. After 3 weeks of treatment, PS-341 injections are stopped for 2 weeks. Some patients continue to receive radiation treatments during the 2-week break, and others do not, depending upon when they enter the trial. The total duration of radiation treatment varies from 6 to 8 weeks, depending on whether the patient received radiation in the region of the head and neck cancer before entering the study. Patients have a blood sample drawn before and after each new PS-341 injection to measure the drug action in the blood and to see how strong and how long the effects on the blood last. They are seen in the clinic at least once a week for a history and physical examination. A blood sample is collected at each visit to look for toxic effects of PS-341. Near the end of treatment, the neurocardiovascular evaluation is repeated, and if the results are abnormal, it is repeated again 3 months after treatment is completed. X-rays or MRI scans are done 12 weeks after radiation therapy has ended and then every few months after that to determine the extent of disease. Patients whose tumor is accessible are asked to undergo a biopsy (removal of a small piece of tumor tissue) on the first and second day after receiving the first PS-341 dose to examine the effect of the drug on the tumor. The PS-341 dose is increased in successive groups of at least 3 patients until the highest dose that can be given safely with radiation is reached. Patients who develop severe side effects from the drug temporarily stop taking it to allow the side effects to improve. If needed, the dose may be decreased. Radiation therapy may also be stopped temporarily in patients who develop severe effects on the mouth, throat or skin. Side effects may be treated with increased fluid (by mouth, stomach tube, or vein), anti-nausea or anti-diarrhea medications, pain medications and medications to boost red or white cell counts or platelets. The drug Florinef may be given to help regulate body fluids and blood pressure.
NCT00021502 Safety and Efficacy of PHP in the Treatment of Shock Associated With Systemic Inflammatory Response Syndrome (SIRS) Completed Apex Bioscience Phase 3 2001-03-01 To determine the safety and effectiveness of pyridoxylated hemoglobin polyoxyethylene conjugate (PHP) administered by continuous intravenous (IV) infusion in systemic inflammatory response syndrome (SIRS) patients with shock. PHP is a human-derived chemically modified hemoglobin preparation. PHP selectively scavenges excess nitric oxide (NO) and does so in a catalytic, concentration-dependent reaction that results in the formation of the non-toxic NO metabolite, nitrate. PHP is postulated to reduce excess, toxic levels of NO while allowing critical beneficial levels of the molecule to persist.
NCT00100412 Hyporeactivity and Gulf War Illness Completed VA Office of Research and Development N/A 1999-10-01 This research project is a follow-up to the prior VA-funded study that found that chronic fatigue reported by many Gulf War veterans may be a symptom of dysfunctional cardiovascular stress response regulation. Specifically, ill veterans had diminished autonomic responses during demanding psychosocial tasks involving high level cognitive processing and emotional stress. There was a close relationship between clinical status of ill veterans and their inability to mount an appropriate physiological response under stress. The main objective of the present investigation is to determine the specific mechanism through which this abnormality may contribute to Gulf War-related chronic fatigue. We also observed that Gulf veterans with posttraumatic stress disorder (PTSD) had the most dampened autonomic activation to stressors involving higher brain activities. The second major focus of this study is to explore the role of a psychiatric disorder, specifically PTSD, as a factor in abnormalities in stress response regulation. This aspect of the study may also provide pertinent information as to the role of stress of military deployment as a contributing factor in post-Gulf War illnesses.
NCT00120432 Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation Completed Khon Kaen University Phase 3 2004-12-01 The purpose of this study is to compare the efficacy on pupillary dilation between the single dose versus the three doses of 1% tropicamide with 10% phenylephrine for complete ocular examination.
NCT00154037 Investigation of Vascular Relaxing Effects of Candesartan and Pioglitazone. Completed Technische Universität Dresden N/A 2005-10-01 The study is designed to test the hypothesis in healthy subjects that candesartan and pioglitazone provide additional vascular relaxing or modulating effects in addition to their blood-pressure and blood glucose level reducing ability, respectively.
NCT00160862 NK-1 Antagonism of SLV317 in Humans Completed Heidelberg University Phase 1 2003-05-01 The primary objective is to determine the effect of a single oral dose of 250 mg SLV 317 on substance P-induced venodilation in the hand vein of healthy male volunteers as compared to placebo.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Phenylephrine Hydrochloride

Condition Name

Condition Name for Phenylephrine Hydrochloride
Intervention Trials
Hypotension 33
Healthy 12
Spinal Anesthesia 11
Cesarean Section Complications 11
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Condition MeSH

Condition MeSH for Phenylephrine Hydrochloride
Intervention Trials
Hypotension 61
Mydriasis 12
Rhinitis 10
Shock 10
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Clinical Trial Locations for Phenylephrine Hydrochloride

Trials by Country

Trials by Country for Phenylephrine Hydrochloride
Location Trials
United States 90
Canada 24
China 18
Egypt 17
Korea, Republic of 10
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Trials by US State

Trials by US State for Phenylephrine Hydrochloride
Location Trials
North Carolina 9
California 8
Illinois 8
New York 7
Tennessee 6
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Clinical Trial Progress for Phenylephrine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Phenylephrine Hydrochloride
Clinical Trial Phase Trials
Phase 4 83
Phase 3 42
Phase 2/Phase 3 9
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Clinical Trial Status

Clinical Trial Status for Phenylephrine Hydrochloride
Clinical Trial Phase Trials
Completed 96
Recruiting 68
Not yet recruiting 62
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Clinical Trial Sponsors for Phenylephrine Hydrochloride

Sponsor Name

Sponsor Name for Phenylephrine Hydrochloride
Sponsor Trials
Cairo University 9
General Hospital of Ningxia Medical University 7
Bayer 6
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Sponsor Type

Sponsor Type for Phenylephrine Hydrochloride
Sponsor Trials
Other 262
Industry 46
NIH 11
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