MK0974 Pivotal Study 1 - WW (With Active Comparator)(0974-011)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00442936
First received: February 28, 2007
Last updated: November 25, 2013
Last verified: November 2013

February 28, 2007
November 25, 2013
February 2007
October 2007   (final data collection date for primary outcome measure)
Pain Freedom at 2 hours post-dose, Pain Relief at 2 hours post-dose, Absence of photophobia, phonophobia, and nausea at 2 hrs post-dose
Not Provided
Complete list of historical versions of study NCT00442936 on ClinicalTrials.gov Archive Site
Sustained Pain-Freedom from 2 to 24 hours after study drug administration, Total Migraine Freedom at 2 hours post-dose, Total Migraine Freedom from 2 to 24 hours post-dose
Not Provided
Not Provided
Not Provided
 
MK0974 Pivotal Study 1 - WW (With Active Comparator)(0974-011)(COMPLETED)
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study to Compare the Response to a Single Treatment With Oral MK0974 With Placebo and Comparator in Subjects With Moderate to Severe Acute Migraine With or Without Aura

The purpose of this study is to investigate the efficacy and safety of MK0974 compared to an approved medication for acute migraine.

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: MK0974 / Duration of Treatment: 1 Day
  • Drug: Comparator: zolmitriptan / Duration of Treatment: 1 Day
  • Drug: Comparator: placebo (unspecified) / Duration of Treatment: 1 Day
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1380
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has at least 1 year history of migraine (with or without aura)
  • Females of child bearing potential must use acceptable contraception throughout trial

Exclusion Criteria:

  • Patient is pregnant/breast-feeding (or is a female expecting to conceive during study period)
  • Patient has history or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or HIV disease
  • Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
  • Patient has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption
  • Patient has a history of cancer within the last 5 years
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00442936
0974-011, MK0974-011, 2006_525
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2013

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