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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 is a Phase 3 study that has completed, run by Amneal Pharmaceuticals. The registered enrollment target is 233 participants.

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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

FieldValue
Enrollment Target 233 participants
Start Date 2009-12
Est. Completion 2010-12
Phase Phase 3

Sponsor

Amneal Pharmaceuticals

8 total trials

What the Registry Record Tells You About NCT01064024

The ClinicalTrials.gov registry entry for NCT01064024 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 233 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 is the first listed.

NCT01064024 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.