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NCT01064024 · ClinicalTrials.gov registry record · Phase 3
Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. Placebo
A Phase 3 study, sponsored by Amneal Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 233
- Enrollment target
NCT01064024: Completed Phase 3 study, sponsored by Amneal Pharmaceuticals.
NCT01064024 is a Phase 3 study that has completed, run by Amneal Pharmaceuticals. The registered enrollment target is 233 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01064024, a Phase 3 study, has completed, sponsored by Amneal Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 233 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as a short term analgesic treatment for the primary symptoms of pain or burning when passing urine associated with uncomplicated urinary tract infections (uUTI)
Interventions
- DRUG Placebo
- DRUG Phenazopyridine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2009-12 |
| Est. Completion | 2010-12 |
| Phase | Phase 3 |
What the finished NCT01064024 record still lists
NCT01064024 is an interventional study that assigns participants to a tested intervention. The registered 233 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 (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01064024 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01064024 about?
NCT01064024 is a clinical study titled "Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. Placebo". This study will evaluate the safety and efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as a short term analgesic treatment for the primary symptoms of pain or burning when passing urine associated with uncomplicated urinary tract infections (uUTI)
What is the current status of trial NCT01064024?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 233 participants. The study started on 2009-12. Estimated completion is 2010-12.
What interventions are being tested in trial NCT01064024?
The interventions under investigation include: Placebo (DRUG), Phenazopyridine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01064024?
This trial is sponsored by Amneal Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01064024's enrollment target sits among peer trials
233 1298th of 2000 higher than 703 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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