Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT01650051
Brief 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.
Detailed Description:
Subjects will make separate self-assessments for severity of pain and burning upon urination using the NRS and self-assessments of their discomfort using the GSAS at designated intervals for 24 hours. Subjects will rate the effectiveness of the study medication using the SASMS at a designated interval for 24 hours.
Study:
NCT01650051
Study Brief:
Protocol Section:
NCT01650051