CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 41 enrolled
Drug / intervention
Treximet +1 moredrug
Likely dose
Treximet 85mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01329562
NCT01329562Phase 4Completed
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Evaluation of CGRP, Estrogen, Cortisol, VIP, α-Amylase, PGE2, PGI2 and ß-Endorphin Levels in Saliva of Menstrual Migraine Patients Before and After Treatment With Treximet™

Cady, Roger, M.D.·interventional·Posted Apr 6, 2011·Updated Apr 9, 2014

In Brief

A Phase 4 clinical trial evaluating Treximet and Placebo for Menstrual Migraine. Completed, enrolled 41 participants across 2 sites.

Detailed Summary

The purpose of this study is to (1) evaluate pain-free efficacy of Treximet™ following treatment of menstrual migraine, (2) investigate levels of Calcitonin gene-related peptide (CGRP), estrogen, cortisol, vasoactive intestinal peptide (VIP), alpha (a)-amylase, Prostaglandin E2 (PGE2), Prostaglandin I2 (PGI2) and beta (ß)-endorphin in saliva before and after Treximet™, (3) evaluate efficacy of Treximet™ to return to baseline levels following treatment, and (4) correlate estrogen in saliva vs. urinary estradiol at mid-luteal, onset of menstrually-related migraine, and after successful treatment with Treximet™.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenstrual Migraine
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 6, 2011
Enrollment StartMay 1, 2011
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.2 years ago

Interventions

Treximetdrug

Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.

Placebodrug

A placebo tablet matching Treximet for oral administration.