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

D

Diamond Headache Clinic

Status and phase

Completed
Phase 3

Conditions

Migraine

Treatments

Drug: Rizatriptan co-administered with Acetaminophen

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00300924
Merck 075-00
Merk 075-00

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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*

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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