TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)
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|ClinicalTrials.gov Identifier: NCT00387881|
Recruitment Status : Completed
First Posted : October 13, 2006
Results First Posted : July 10, 2009
Last Update Posted : December 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Migraine, Without Aura||Drug: sumatriptan succinate / naproxen sodium Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||679 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Tolerability of TREXIMA* (Sumatriptan Succinate/Naproxen Sodium) for a Single Moderate or Severe Headache in Adults Diagnosed With Probable Migraine Without Aura (ICHD-II 1.6.1) (*TREXIMET)|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
|Placebo Comparator: Placebo||
Placebo to match Treximet tablets
Drug: sumatriptan succinate / naproxen sodium
sumatriptan 85mg / naproxen sodium 500mg
- Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. [ Time Frame: 2 hours through 24 hours after Treatment ]Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine.
- Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment [ Time Frame: 0.5, 1, and 4 hours after Treatment ]Pain-Free is defined as post-treatment headache pain severity of none in subjects who have not used rescue medication prior to or at the time of the assessment.
- Sustained Headache Relief 2-24 Hours After Treatment [ Time Frame: 2-24 hours after treatment ]Sustained pain relief was defined as having pain relief (mild or no pain) at 2 hours w/o any moderate or severe pain during 2-24 hour period post-treatment, without rescue medication.
- Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment [ Time Frame: 0.5, 1, 2, and 4 hours after treatment ]Pain relief was defined as reduction of headache pain from a baseline severity of moderate or severe to none or mild at the given time.
- Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment [ Time Frame: 0 - 24 hours after treatment ]Rescue medication defined as additional medication (i.e. sumatriptan/naproxen sodium as open-label rescue or other medication as permitted per protocol), taken by subject for the treatment of headache pain or other symptoms associated with the headache attack.
- Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment [ Time Frame: 1-2, and 2- 4 hours after treatment ]Intermediate sustained pain relief was defined as achieving headache pain relief (from moderate or severe pain at baseline to mild or no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours). (Intermediate=Intermed.)
- Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours [ Time Frame: 1-2 and 2-4 hours after treatment ]Intermediate sustained pain free was defined as achieving headache pain-free (moderate or severe pain to no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours).(Intermediate=Intermed.)
- Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment [ Time Frame: 2 and 4 hours after treatment ]Neck pain, sinus pain, photophobia, phonophobia and nausea are considered headache-associated symptoms.(Headache-associated=Headache-Assoc.)
- Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score [ Time Frame: 0 - 24 hours after treatment ]Patient Perception of Migraine Questionnaire-Revised(PPMQ-R) evaluates subject satisfaction with treatment 24 hours post-dose using validated questions. Questions are analyzed on 4 subscale scores (efficacy, functionality, ease-of-use, and tolerability) and total score. Scores range from 0-100, with the higher scores indicating better satisfaction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387881
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|