Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea
|ClinicalTrials.gov Identifier: NCT00250458|
Recruitment Status : Completed
First Posted : November 8, 2005
Results First Posted : June 23, 2010
Last Update Posted : November 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: Comparator: Rizatriptan Drug: Comparator: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||346 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Elimination of Migraine-Associated Nausea in Migraine Patients Treated With Rizatriptan Orally Disintegrating Tablet (ODT)|
|Study Start Date :||March 2006|
|Primary Completion Date :||October 2006|
|Study Completion Date :||October 2006|
Rizatriptan (MK0462)10 mg orally disintegrating tablet/oral lyophilisate
Drug: Comparator: Rizatriptan
One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack.
Placebo Comparator: 2
Drug: Comparator: Placebo
One dose matching placebo to Rizatriptan to treat one migraine attack.
- Participants With Elimination of Nausea at 2 Hours Postdose [ Time Frame: At 2 hours after treatment ]Participants reporting the absence of nausea at 2 hours post treatment. Absence or presence of nausea was recorded by the participants in an electronic diary. Absence is defined as no nausea at 2 hours post-treatment.
- Participants With Pain Relief at 2 Hours Postdose [ Time Frame: 2 hours after treatment ]Participants reporting pain relief defined as a reduction of pain severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250458
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|