A Research Study of MK0633 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0633-009)(COMPLETED)

NCT ID: NCT00418613

Last Updated: 2015-09-03

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

PHASE2

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-03-31

Brief Summary

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A clinical study to evaluate the efficacy and safety of MK0633 in patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

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

MK0633

Group Type EXPERIMENTAL

MK633

Intervention Type DRUG

MK0633 100mg capsules qd for a 12-wk treatment period.

2

Placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo (unspecified)

Intervention Type DRUG

MK0633 100mg Pbo capsules for a 12-wk treatment period

Interventions

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MK633

MK0633 100mg capsules qd for a 12-wk treatment period.

Intervention Type DRUG

Comparator: Placebo (unspecified)

MK0633 100mg Pbo capsules for a 12-wk treatment period

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Documented COPD defined by clinical history and spirometry, with symptoms including dyspnea, wheezing, chest tightness, cough, sputum production, or nocturnal awakening
* Male or postmenopausal females 40 -75 years of age

Exclusion Criteria

* Impaired renal function
* History of chronic liver disease or persistent liver function test (LFT) abnormalities
* History of recent cardiovascular clinical event
* Evidence of another clinically significant, active pulmonary disorder such as bronchiectasis or asthma
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 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

References

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Bernstein JA, Liu N, Knorr BA, Smugar SS, Hanley WD, Reiss TF, Greenberg S. MK-0633, a potent 5-lipoxygenase inhibitor, in chronic obstructive pulmonary disease. Respir Med. 2011 Mar;105(3):392-401. doi: 10.1016/j.rmed.2010.09.021. Epub 2010 Nov 13.

Reference Type DERIVED
PMID: 20970976 (View on PubMed)

Other Identifiers

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MK0633-009

Identifier Type: -

Identifier Source: secondary_id

2006_509

Identifier Type: -

Identifier Source: secondary_id

0633-009

Identifier Type: -

Identifier Source: org_study_id

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