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NCT01650051 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as an Analgesic for Short-Term Treatment in Female Subjects Suffering From Moderate-to-Severe Pain and Burning Upon Urination Associated With Uncomplicated Urinary Tract Infections (uUTI)
A Phase 3 study, sponsored by Amneal Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 424
- Enrollment target
NCT01650051 is a Phase 3 study that has completed, run by Amneal Pharmaceuticals. The registered enrollment target is 424 participants.
The verdict
NCT01650051, a Phase 3 study, has completed, sponsored by Amneal Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 424 participants
- Enrollment target
Study Summary
The primary objective is to evaluate the safety and efficacy of Phenazopyridine HCl Tablets, USP 200 mg as a short term analgesic treatment of pain upon urination associated with Uncomplicated Urinary Tract Infections (uUTI). The secondary exploratory objective is to evaluate safety and efficacy of Phenazopyridine HCl Tablets, USP 200 mg as a short term analgesic treatment of burning upon urination associated with uUTI.
Interventions
- DRUG Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg
- DRUG Phenazopyridine Hydrochloride Tables, USP 200 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 424 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01650051
The ClinicalTrials.gov registry entry for NCT01650051 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 424 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amneal Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg is the first listed.
NCT01650051 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01650051 about?
NCT01650051 is a clinical study titled "Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as an Analgesic for Short-Term Treatment in Female Subjects Suffering From Moderate-to-Severe Pain and Burning Upon Urination Associated With Uncomplicated Urinary Tract Infections (uUTI)". The primary objective is to evaluate the safety and efficacy of Phenazopyridine HCl Tablets, USP 200 mg as a short term analgesic treatment of pain upon urination associated with Uncomplicated Urinary Tract Infections (uUTI). The secondary exploratory objective is to evaluate safety and efficacy of...
What is the current status of trial NCT01650051?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 424 participants. The study started on 2012-02. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01650051?
The interventions under investigation include: Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg (DRUG), Phenazopyridine Hydrochloride Tables, USP 200 mg (DRUG).
Who is sponsoring clinical trial NCT01650051?
This trial is sponsored by Amneal Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
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