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A Study of Gastric Delay in Migraine Patients (3207-003)

NCT ID: NCT00548353

Last Updated: 2014-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-02-28

Brief Summary

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A study to assess safety and PK of an investigational drug in migraine patients during and between migraine attacks.

Detailed Description

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Conditions

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Migraine Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

MK3207 Orally administered to patients with water. During each period (with and without acute migraine).

Group Type EXPERIMENTAL

MK3207

Intervention Type DRUG

M3207 (20 mg); patients will be administered a single dose of 100 mg of MK3207 (i.e., 5 x20-mg tablets).

2

MK3207 placebo as tablets will be Orally administered to patients with water. During each period (with and without acute migraine).

Group Type PLACEBO_COMPARATOR

Comparator: Placebo (unspecified)

Intervention Type DRUG

M3207 (20 mg) Pbo; patients will be administered a single dose of 100 mg of MK3207 Pbo (i.e., 5 x20-mg tablets).

Interventions

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MK3207

M3207 (20 mg); patients will be administered a single dose of 100 mg of MK3207 (i.e., 5 x20-mg tablets).

Intervention Type DRUG

Comparator: Placebo (unspecified)

M3207 (20 mg) Pbo; patients will be administered a single dose of 100 mg of MK3207 Pbo (i.e., 5 x20-mg tablets).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Non-smoking male or female between 18 to 45 years of age
* Patient typically has between 2 and 10 migraine attacks per month, rated as moderate or severe

Exclusion Criteria

* Patient has any other medical conditions other than migraine
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Countries

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United States

Other Identifiers

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MK3207-003

Identifier Type: -

Identifier Source: secondary_id

2007_599

Identifier Type: -

Identifier Source: secondary_id

3207-003

Identifier Type: -

Identifier Source: org_study_id