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
  Purpose

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


Condition Intervention Phase
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Enrollment: 1380
Study Start Date: February 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442936

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00442936     History of Changes
Other Study ID Numbers: 0974-011, MK0974-011, 2006_525
Study First Received: February 28, 2007
Last Updated: November 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Zolmitriptan
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014