Last updated: 11/06/2018 23:51:29
A Randomized, Double-Blind, Single-Attack, Placebo-Controlled, Parallel Group Evaluation of the Efficacy and Tolerability of Trexima tablets vs placebo when administered during the mild pain phase of a migraine
Clinicaltrials.gov ID
Not applicable
EudraCT ID
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EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomized, Double-Blind, Single-Attack, Placebo-Controlled, Parallel Group Evaluation of the Efficacy and Tolerability of Trexima tablets vs placebo when administered during the mild pain phase of a migraine
Trial description: A Randomized, Double-Blind, Single-Attack, Placebo-Controlled, Parallel Group Evaluation of the Efficacy and Tolerability of Trexima tablets vs placebo when administered during the mild pain phase of a migraine
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, Winner P, McDonald SA, Lener S. Optimizing efficacy in the acute treatment of migraine: evaluation of the clinical benefits of treatment paradigm and combination therapy (fixed single-tablet formulation of sumatriptan 85mg RT Technology™ and naproxen sodium 500mg, SumaRT/Nap). Cephalalgia 2006;26 (Suppl 11):1395 (Abs No PE.19).
Burch SP, Landy S, Runken MC, Silberstein S. Impact of Early versus Late Intervention on Productivity and Clinical Disability in Migraineurs. Cephalalgia 2007; Vol 27; 702.
Dodick D, Kaniecki R, Mathew N, Kori S, McDonald SA, Nelsen A. Traditional and Non-Traditional Migraine-Associated Symptoms: Incidence and Consistent Responsiveness Across 4 Migraine Attacks With Sumatriptan 85mg RT Technology and Naproxen Sodium 500mg (SumaRT/Nap) Neurology 2007; Vol 68 (Suppl 1): A195.
Silberstein S, Goldstein J, Mannix LK, Sheftell F, Byrd S, Ames MH, McDonald SA, Lener S. A new migraine therapy: efficacy and tolerability of a fixed single-tablet formulation of sumatriptan RT TechnologyTM and naproxen sodium in the early intervention paradigm. Headache 2006;46(5):858 (Abs No F44).
Taylor FR, Heiring J, Messina E, Ames M, Byrd S, McDonald S, Burch S. Productivity and patient satisfaction benefits of a fixed single-tablet formulation of sumatriptan with RT TechnologyTM and naproxen sodium in an early intervention paradigm. Headache 2006;46(5):859 (Abs No F46).
Taylor FR, Heiring J; Messina E; Braverman-Panza J, Ames MH; Byrd S; McDonald SA; Burch SP. Sumatriptan/Naproxen Sodium as Early Intervention for Migraine: Effects on Functional Ability, Productivity, and Satisfaction in Two Randomized, Double-Blind, Placebo-Controlled Studies. J Clin Outcomes Manage 2007 Apr; 14(4): 195-204.
Medical condition
Migraine Disorders
Product
sumatriptan
Collaborators
Not applicable
Study date(s)
October 2004 to April 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
2005-01-04
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
Not applicable
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