An Investigational Drug Study In Patients With COPD (Chronic Obstructive Pulmonary Disease) (MK-0873-005)

NCT ID: NCT00132730

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 604 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-01
• Study Completion Date: 2005-08-17

Brief Summary

This is a study to evaluate the effectiveness and tolerability of a once-daily oral medication (MK-0873) for the treatment of COPD (chronic obstructive pulmonary disease) to determine whether the study drug leads to an improvement in pulmonary (lung) function, as well as symptoms, and quality of life.

Detailed Description

Following a three-week run-in period (Period I) during which participants received placebo, participants entered into a 12-week double-blind treatment period (Period II) during which they received daily doses of either one of three doses of MK-0873 or placebo. Period I and Period II made up the Base Study. Following the 12-week treatment period in the Base Study, participants were invited to continue in an optional 12-week double-blind extension study (Period III, EXT1). Participants who received any dose of MK-0873 in the Base Study continued on MK-0873 2.5 mg daily in Period III while participants in the placebo arm of the Base Study continued on placebo daily. Following EXT1, participants were invited to continue in an optional open-label second extension study (EXT2) which was to last 80 weeks (Period IV: 28 weeks, Period V: 52 weeks). In EXT2, participants who had been taking MK-0873 2.5 mg in the Base Study were allocated to MK-0873 2.5 mg plus usual care, while participants who had been taking the other two doses of MK-0873 or placebo in the Base Study were allocated to either MK-0873 2.5 mg plus usual care or to usual care alone.

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MK-0873 2.5 mg

Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)

Group Type: EXPERIMENTAL

MK-0873 2.5 mg

Intervention Type: DRUG

Placebo to MK-0873

Intervention Type: DRUG

MK-0873 1.25 mg

Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)

Group Type: EXPERIMENTAL

MK-0873 1.25 mg

Intervention Type: DRUG

Placebo to MK-0873

Intervention Type: DRUG

MK-0873 0.75 mg

Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)

Group Type: EXPERIMENTAL

MK-0873 0.75 mg

Intervention Type: DRUG

Placebo to MK-0873

Intervention Type: DRUG

Placebo

Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)

Group Type: PLACEBO_COMPARATOR

Placebo to MK-0873

Intervention Type: DRUG

MK-0873 2.5 mg + Usual Care

Participants receive MK-0873 2.5 mg tablets once daily plus usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks during Periods IV and V (EXT2)

Group Type: EXPERIMENTAL

MK-0873 2.5 mg

Intervention Type: DRUG

Usual Care

Intervention Type: DRUG

Usual Care

Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks during Periods IV and V (EXT2)

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: DRUG

Interventions

MK-0873 2.5 mg

Intervention Type: DRUG

MK-0873 1.25 mg

Intervention Type: DRUG

MK-0873 0.75 mg

Intervention Type: DRUG

Placebo to MK-0873

Intervention Type: DRUG

Usual Care

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Males and females, 40 to 75 years old, with a history consistent with COPD (chronic obstructive pulmonary disease)
• Lung function tests that meet the requirements of the study

Exclusion Criteria

• Severe and unstable medical conditions other than COPD (chronic obstructive pulmonary disease)
• Use of continuous oxygen therapy
• Cardiac (heart) arrhythmias
• Other lung disease
• History of colitis (inflammation of the colon)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2005_015

Identifier Type: OTHER

Identifier Source: secondary_id

0873-005

Identifier Type: -

Identifier Source: org_study_id