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 @ 9:31 PM
Ignite Modification Date:
2025-12-24 @ 9:31 PM
NCT ID:
NCT00433732
Brief Summary:
To determine the efficacy of the Trexima versus placebo as assessed by pain relief and the incidences of photophobia, phonophobia and nausea at 2 hours after treatment as the primary endpoints.
Detailed Description:
The primary objective of this study is to determine the efficacy of the Trexima versus placebo as assessed by pain relief and the incidences of photophobia, phonophobia and nausea at 2 hours after treatment as the primary endpoints. Another objective of this study is to evaluate the efficacy of Trexima when compared to the individual components (sumatriptan and naproxen sodium) using sustained pain-free as the endpoint. It is the intent that this study be sufficiently powered to detect differences that are clinically meaningful and statistically significant in order to meet both objectives.
Study:
NCT00433732
Study Brief:
Protocol Section:
NCT00433732