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

NCT00132730 | Terminated Phase 2 Results

• 2 other identifiers: 0873-0052005_015
• Study Type: interventional
• Target: 604
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pre-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)

  FEV1 is a measure, in liters, of the amount of air expired in 1 second. Measured values were averaged during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment. For participants who did not have any measurements over the last 4 weeks of the 12-week treatment period, the last available on-treatment measurement was carried forward.

  Pre-dose at Baseline and Treatment Weeks 8, 10 and 12

Secondary Outcomes (7)

• Change From Baseline in Overall Daytime Symptoms Score

  Baseline and Treatment Weeks 8, 10 and 12

• Change From Baseline in Total Daily Beta-agonist Use

  Baseline and Treatment Weeks 8, 10 and 12

• Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Response

  Baseline and Treatment Weeks 8 and 12

• Transition Dyspnea Index (TDI) Focal Score

  Baseline and Treatment Week 12

• Change From Baseline in Shortness of Breath Questionnaire (SOBQ) Response

  Baseline and Treatment Weeks 8 and 12

Study Arms (6)

MK-0873 2.5 mg

EXPERIMENTAL

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)

Drug: MK-0873 2.5 mg; Drug: Placebo to MK-0873

MK-0873 1.25 mg

EXPERIMENTAL

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)

Drug: MK-0873 1.25 mg; Drug: Placebo to MK-0873

MK-0873 0.75 mg

EXPERIMENTAL

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)

Drug: MK-0873 0.75 mg; Drug: Placebo to MK-0873

Placebo

PLACEBO COMPARATOR

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)

Drug: Placebo to MK-0873

MK-0873 2.5 mg + Usual Care

EXPERIMENTAL

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)

Drug: MK-0873 2.5 mg; Drug: Usual Care

Usual Care

ACTIVE COMPARATOR

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)

Drug: Usual Care

Interventions

MK-0873 2.5 mg DRUG

MK-0873 2.5 mg; MK-0873 2.5 mg + Usual Care

MK-0873 1.25 mg DRUG

MK-0873 1.25 mg

MK-0873 0.75 mg DRUG

MK-0873 0.75 mg

Placebo to MK-0873 DRUG

MK-0873 0.75 mg; MK-0873 1.25 mg; MK-0873 2.5 mg; Placebo

Usual Care DRUG

MK-0873 2.5 mg + Usual Care; Usual Care

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive

Interventions

MK 0873

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The extension studies were terminated based on data from the completed base study suggesting that MK-0873, at doses up to 2.5 mg per day, demonstrated no benefits versus placebo in lung function or symptoms in participants with COPD.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2005
• First Posted: August 22, 2005
• Study Start: June 1, 2004
• Primary Completion: August 17, 2005
• Study Completion: August 17, 2005
• Last Updated: October 12, 2018
• Results First Posted: May 26, 2014

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share