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

Tracking Information

First Received Date ^ICMJE

March 9, 2006

Last Updated Date

May 27, 2008

Start Date ^ICMJE

March 2006

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00300924 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Migraine

Intervention ^ICMJE

Drug: Rizatriptan co-administered with Acetaminophen

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

January 2007

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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*

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00300924

Responsible Party

Karin E. Brooks, BSN, RN Director of Clinical Research, Diamond Headache Clinic

Study ID Numbers ^ICMJE

Merck 075-00, Merk 075-00

Study Sponsor ^ICMJE

Diamond Headache Clinic

Collaborators ^ICMJE

Merck

Investigators ^ICMJE

Study Director:

Merle Diamond, M.D.

Diamond Headache Clinic

Information Provided By

Diamond Headache Clinic

Verification Date

May 2008

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