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NCT01293201 · ClinicalTrials.gov registry record · Phase 3
Trial of STAHIST in Seasonal Allergic Rhinitis
A Phase 3 study, sponsored by Magna Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 290
- Enrollment target
NCT01293201 is a Phase 3 study that has completed, run by Magna Pharmaceuticals. The registered enrollment target is 290 participants.
The verdict
NCT01293201, a Phase 3 study, has completed, sponsored by Magna Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 290 participants
- Enrollment target
Study Summary
The overall development plan is to show that the combination of tried-and-proven decongestant/antihistamine ingredients (pseudoephedrine hydrochloride and chlorpheniramine maleate), plus a very small amount of belladonna alkaloids (.24 mg atropine sulfate) is a comprehensive, safe and effective B.I.D. drug treatment regimen, indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Treated symptoms include nasal congestion, sneezing, rhinorrhea, itchy nose, itchy/watery eyes, and post nasal drip syndrome \[reduction in tickly cough (acute or chronic), mucus in the back of the throat, sore throat, and hoarseness\]. Considering the favorable safety and efficacy results of Phase 1 and Phase 2, the purpose of Phase 3 is to assess and compare the safety and efficacy of the study drug in a larger group comparatively with a placebo control group. Objectives: A) To report and compare total symptom scores (TSS) by SAR subjects rating the efficacy of STAHIST vs. placebo in relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over the two-week study period. B) Report any side effects or adverse drug reactions and rate the severity of any incident. C) Compare and report each symptom score, total nasal symptom scores (TNSS), and post-nasal drip symptom scores (PND-S) between the two study arms.
Interventions
- DRUG Placebo
- DRUG STAHIST
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01293201
The ClinicalTrials.gov registry entry for NCT01293201 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 290 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Magna Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01293201 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01293201 about?
NCT01293201 is a clinical study titled "Trial of STAHIST in Seasonal Allergic Rhinitis". The overall development plan is to show that the combination of tried-and-proven decongestant/antihistamine ingredients (pseudoephedrine hydrochloride and chlorpheniramine maleate), plus a very small amount of belladonna alkaloids (.24 mg atropine sulfate) is a comprehensive, safe and effective B.I....
What is the current status of trial NCT01293201?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 290 participants. The study started on 2011-03. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01293201?
The interventions under investigation include: Placebo (DRUG), STAHIST (DRUG).
Who is sponsoring clinical trial NCT01293201?
This trial is sponsored by Magna Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
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