Last updated: 11/07/2018 19:35:42
A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and tolerability of oral sumatriptan 25mg, 50mg, and 100mg tablets for a single moderate or severe headache in adults diagnosed with migrainous disorder International Headache Society (IHS) 1.7.
Clinicaltrials.gov ID
Not applicable
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 oral sumatriptan 25mg, 50mg, and 100mg tablets for a single moderate or severe headache in adults diagnosed with migrainous disorder International Headache Society (IHS) 1.7.
Trial description: A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and tolerability of oral sumatriptan 25mg, 50mg, and 100mg tablets for a single moderate or severe headache in adults diagnosed with migrainous disorder International Headache Society (IHS) 1.7.
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:
Lipton R, Dodick D, Cady R, et al. Headache response sustained through 4 hours in adults with probable migraine in a controlled clinical study-Should response rates include subjects who achieve and then lose response within 4 hours? Headache 2004;44:482.
Tepper S, Dodick D, Cady R, et al. Oral sumatriptan for probable migraine without aura (2004 IHS 1.6.1): results of a randomized, double-blind, placebo-controlled study. Headache 2004;44:477.
Medical condition
Migraine Disorders
Product
sumatriptan
Collaborators
Not applicable
Study date(s)
August 2002 to April 2003
Type
Not applicable
Phase
4
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
2003-09-04
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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