Last updated: 11/04/2018 13:01:21
TREXIMET (formerly known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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)
Trial description: This study was designed to determine the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Pain-Free at 2 hours post-dose and Sustained Pain-Free from 2-24 hours post-dose.
Timeframe: 2 hours through 24 hours after Treatment
Secondary outcomes:
Freedom from Headache pain at 0.5, 1, and 4 hours after Treatment
Timeframe: 0.5, 1, and 4 hours after Treatment
Sustained headache relief 2-24 hours after Treatment
Timeframe: 2-24 hours after treatment
Headache relief at 4, 2, 1 and 0.5 hours after treatment
Timeframe: 0.5, 1, 2, and 4 hours after treatment
Subjects who used Rescue medication from 0 - 24 hours after treatment
Timeframe: 0 - 24 hours after treatment
Intermediate Sustained Pain Relief: Post-dose at intervals of 2-4 hours and 1-2 hours after treatment
Timeframe: 1-2, and 2- 4 hours after treatment
Intermediate Sustained Pain-Free: Post-dose at intervals of 2-4 hours and 1-2 hours
Timeframe: 1-2 and 2-4 hours after treatment
Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at time intervals of 4 and 2 hours after treatment
Timeframe: 2 and 4 hours after treatment
Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score
Timeframe: 0 - 24 hours after treatment
Interventions:
Enrollment:
679
Primary completion date:
2008-20-02
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Silberstein S, Lipton RB, Goldstein J, Aurora SK, White J, Ochs-Ross R, Lener SE, McDonald SA. Evaluation of a New Fixed-dose Single Tablet of Sumatriptan Formulated with RT Technology and Naproxen Sodium (SumaRT/Nap) for the Acute Treatment of Probable Migraine without Aura. Headache 2008: presented at the American Headache Society Meeting, Boston, MA.
Stephen Silberstein, Susan A. McDonald, Jerome Goldstein, Sheena Aurora, Shelly E. Lener, Jonathan White, Michael C. Runken, Jane Saiers.Sumatriptan/Naproxen Sodium for the Acute Treatment of Probable Migraine Without Aura .Cephalalgia.2014;34(4):268-279
Medical condition
Migraine, Without Aura
Product
sumatriptan
Collaborators
Not applicable
Study date(s)
September 2006 to February 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- At least a 6 month history of probably migraine (6 migraine attacks per month)
- Males and women of childbearing potential on a adequate contraception.
- Physician diagnosis of migraine; history of triptan or ergot use; history of headache prophylaxis use
- Pregnant and/or nursing mother
Inclusion and exclusion criteria
Inclusion criteria:
- At least a 6 month history of probably migraine (6 migraine attacks per month) -Males and women of childbearing potential on a adequate contraception.
Exclusion criteria:
- Physician diagnosis of migraine; history of triptan or ergot use; history of headache prophylaxis use -Pregnant and/or nursing mother -History of cardiovascular disease. -Uncontrolled hypertension. -Basilar or Hemiplegic migraine -History of stroke or transient ischemic attacks (TIA). -History of epilepsy or treated with anti-epileptics within the past 5 years. -Impaired hepatic or renal function. -History of gastrointestinal bleeding or ulceration. -Allergy or hypersensitivity to Aspirin or any other NSAID. -Allergy or hypersensitivity to triptans. -Participated in an investigational drug trial in the previous 4 weeks.
Trial location(s)
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85014
Status
Study Complete
Location
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53209-0996
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94596
Status
Study Complete
Showing 1 - 6 of 70 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2008-20-02
Actual study completion date
2008-20-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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