Last updated: 11/07/2018 04:49:57
MT400-301 GR43175 A Double-blind, Multicenter, Randomized, Placebo-controlled Single Dose Study to Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migraine Headaches
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: MT400-301 GR43175 A Double-blind, Multicenter, Randomized, Placebo-controlled Single Dose Study to Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migraine Headaches
Trial description: MT400-301 GR43175 A Double-blind, Multicenter, Randomized, Placebo-controlled Single Dose Study to Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migraine Headaches
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Brandes JL, Kudrow D, Stark S, O’Carroll CP, Adelman JU, O’Donnell F, Spruill S, Alexander WJ, Barrett P, Lener S. Superior efficacy of combination therapy over monotherapy: results of a fixed single-tablet formulation of sumatriptan RT TechnologyTM and naproxen sodium in the acute treatment of migraine in the traditional treatment paradigm. Headache 2006;46(5):860 (Abs No F48).
Brandes JL, Kudrow D, Stark SR, O’Carroll CP, Adelman JU, Alexander WJ, Spruill SE, Barrett PS, Lener SE. Sumatriptan-Naproxen for Acute Treatment of Migraine: A Randomized Trial. JAMA 2007; 297(13): 1443-1454.
Brandes JL, O’Carroll PC, Mannix LK, Lener S, Littlefield D, Alexander WJ. Therapeutic clinical benefits of a new single-tablet formulation of sumatriptan formulated with RT Technology™ and naproxen sodium. Cephalalgia 2005; 25: 860.
Brandes JL, O’Carroll PC, Mannix LK, Lener S, McDonald SA, Alexander WJ. Sustained clinical benefits of a new single-tablet formulation of sumatriptan formulated with RT Technology™ and naproxen sodium. Presented at: National Headache Foundation’s 3rd Annual Headache Research Summit; February 15-16, 2006; Palm Springs, CA.
Cady R, Rothrock J, Blumenthal H, Ward T, Ames M, Burch S. Treatment satisfaction with a new single-tablet formulation of sumatriptan formulated with RT TechnologyTM and naproxen sodium. Neurology 2006;66 (5 Suppl 2):A42 (Abs No P01.122).
Diamond M, Mannix LK, White J, McDonald SA. Evaluation of the Relationship of Demographic and Baseline Characteristics to Efficacy of a Fixed-Dose, Single-Tablet Formulation of Sumatriptan 85mg Formulated with RT Technology™ and Naproxen Sodium 500mg (SumaRT/Nap) for the acute treatment of migraine. Poster presentation at: National Headache Foundation’s 5th Annual Headache Research Summit; February 19, 2008; Scottsdale, AZ.
Landy S, DeRossett SE; Rapoport A; Rothrock J; Ames M; McDonald SA, Burch SP. Two Double-Blind, Multicenter Randomized, Placebo-Controlled Single-Dose Studies of Sumatriptan/Naproxen Sodium in the Acute Treatment of Migraine: Function, Productivity and Satisfaction Outcomes. Medscape General Medicine 2007;9(2):53.
Landy S, Smith T, Diamond M, Rapoport A, Ames M, Burch S. Impact of a new single-tablet formulation of sumatriptan formulated with RT technologyTM and naproxen sodium on workplace productivity and activity time. Neurology 2006;66 (5 Suppl 2):A43 (Abs No P01.126).
Landy S, White J, Lener SE, McDonald SA. Utilization of a Novel Clinical Endpoint, Sustained Pain-Free and No Adverse Events, to Evaluate a Newly Developed Combination Medication, a Fixed-Dose Single Tablet of Sumatriptan 85mg RT/Naproxen Sodium 500mg, for the Acute Treatment of Migraine. Headache 2008: S44.
Landy S, White JD, Lener SE, McDonald SA. Evaluation of Combination Therapy (Sumatriptan/Naproxen Sodium) versus Monotherapy for the Acute Treatment of Migraine Using a Novel Clinical Endpoint: Sustained Pain Free and No Adverse Events. Neurology 2008: A353-354.
Silberstein SD, Stark D, DeRossett SE, Taylor D, McDonald SA, Lener S. Superior clinical benefits of a new single-tablet formulation of sumatriptan formulated with RT TechnologyTM and naproxen sodium. Neurology 2006;66(5 Suppl 2):A254-A255 (Abs No S35.001).
Winner PK, Brandes JL, Lener SE, Derosier F, White J, and McDonald SA. Evaluation of the Relationship Body Mass Index (BMI) to Response and Tolerability after Treatment with a Single Fixed-Dose Tablet of Sumatriptan 85mg formulated with RT Technology/Naproxen Sodium 500mg (SumaRT/Nap) for the Acute Treatment of Migraine. Headache 2008: S47.
Medical condition
Migraine Disorders
Product
sumatriptan
Collaborators
Not applicable
Study date(s)
July 2004 to January 2005
Type
Not applicable
Phase
2/3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
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
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-11-01
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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