Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00250458
First received: November 7, 2005
Last updated: June 24, 2010
Last verified: June 2010

November 7, 2005
June 24, 2010
March 2006
October 2006   (final data collection date for primary outcome measure)
Participants With Elimination of Nausea at 2 Hours Postdose [ Time Frame: At 2 hours after treatment ] [ Designated as safety issue: No ]
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.
Percentage of patients with elimination of migraine-associated nausea at 2 hours postdose as recorded in patient diary
Complete list of historical versions of study NCT00250458 on ClinicalTrials.gov Archive Site
Participants With Pain Relief at 2 Hours Postdose [ Time Frame: 2 hours after treatment ] [ Designated as safety issue: No ]
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.
Percentage of patients with a 2 hour pain relief: 4-point headache severity scale as recorded in patient diary
Not Provided
Not Provided
 
Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea
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 to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Migraine
  • Drug: Comparator: Rizatriptan
    One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack.
  • Drug: Comparator: Placebo
    One dose matching placebo to Rizatriptan to treat one migraine attack.
  • Experimental: 1
    Rizatriptan (MK0462)10 mg orally disintegrating tablet/oral lyophilisate
    Intervention: Drug: Comparator: Rizatriptan
  • Placebo Comparator: 2
    matching placebo
    Intervention: Drug: Comparator: Placebo
Freitag F, Taylor FR, Hamid MA, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Elimination of Migraine-Associated Nausea in Patients Treated with Rizatriptan Orally Disintegrating Tablet (ODT): A Randomized, Double-Blind, Placebo-Controlled Study. Headache. 2007 Nov 28; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
346
November 2006
October 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 6-month history of migraine, moderate to severe migraine attacks with nausea, 1-6 migraine attacks per month

Exclusion Criteria:

  • Heart disease, high blood pressure
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00250458
2005_081, MK0462-074
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP