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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: Completed Phase 3 study, sponsored by Magna Pharmaceuticals.
NCT01293201 is a Phase 3 study that has completed, run by Magna Pharmaceuticals. The registered enrollment target is 290 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG STAHIST
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
What the finished NCT01293201 record still lists
NCT01293201 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01293201 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01293201's enrollment target sits among peer trials
290 1171st of 2000 higher than 828 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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