A Study of Rizatriptan Co-Administered With Acetaminophen for the Treatment of Acute Migraine

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Diamond Headache Clinic
ClinicalTrials.gov Identifier:
NCT00300924
First received: March 9, 2006
Last updated: May 27, 2008
Last verified: May 2008

March 9, 2006
May 27, 2008
March 2006
January 2007   (final data collection date for primary outcome measure)
To compare the efficacy of rizatriptan co-administered with acetaminophen to placebo, acetaminophen and rizatriptan for the acute treatment of migraine, as measured by the percentage of patients with pain relief at 2 hours.
Same as current
Complete list of historical versions of study NCT00300924 on ClinicalTrials.gov Archive Site
  • 24 hour sustained pain relief
  • Pain relief at 30, 45,60,90 minutes and 4 hours post dose
  • Pain freedom at 30,45,60,90 minutes and 2 and 4 hours post dose
  • 24 sustained pain freedom
  • Associated symptoms of phonophobia, photophobia, nausea and vomiting
  • Functional disability
  • Use of rescue medication
  • Self-reported adverse experiences
  • 24 hour sustained pain relief
  • Pain relief at 30, 45,60,90 minutes and 4 hours post dose
  • Pain freedom at 30,45,60,90 minutes and 2 and 4 hours post dose
  • 24 sustained pain freedom
  • Associated sypmtoms of phonophobia, photophobia, nausea and vomiting
  • Functional disability
  • Use of rescue medication
  • Self-reported adverse experiences
Not Provided
Not Provided
 
A Study of Rizatriptan Co-Administered With Acetaminophen for the Treatment of Acute Migraine
A Double-Blind, Double-Dummy, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10mg Co-Administered With Acetaminophen for the Treatment of Acute Migraine.

The purpose of this study is to test an experimental drug combination of two medications currently approved by the Food and Drug Administration (FDA) for migraine headache or other pain. These are called rizatriptan given with acetaminophen.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Migraine
Drug: Rizatriptan co-administered with Acetaminophen
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
January 2007
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is at least 18 years of age
  • Subject has at least a 6 month history of migraine, with or without aura
  • Subject can distinguish between migraine attacks and other types of headaches
  • Subject of childbearing potential agrees to use adequate contraception

Exclusion Criteria:

  • Subject typically has fewer than 1 or greater than 6 migraine attacks per month
  • Subject typically has greater than 10 headache days per month
  • Subject has evidence of ischemic heart disease
  • Subject has uncontrolled high blood pressure
  • Subject has a history, within 1 year, or current evidence of drug or alcohol abuse

*This list is not all inclusive*

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00300924
Merck 075-00, Merk 075-00
Yes
Karin E. Brooks, BSN, RN Director of Clinical Research, Diamond Headache Clinic
Diamond Headache Clinic
Merck Sharp & Dohme Corp.
Study Director: Merle Diamond, M.D. Diamond Headache Clinic
Diamond Headache Clinic
May 2008

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