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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00132730
First received: August 3, 2005
Last updated: April 25, 2014
Last verified: April 2014
Results First Received: March 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Lung Diseases
Pulmonary Disease, Chronic Obstructive
Interventions: Drug: MK-0873 2.5 mg
Drug: MK-0873 1.25 mg
Drug: MK-0873 0.75 mg
Drug: Placebo to MK-0873
Drug: Usual Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
MK-0873 0.75 mg Base Study Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base)
MK-0873 1.25 mg Base Study Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base)
MK-0873 2.5 mg Base Study 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)
Placebo Base Study 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)
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 in Periods IV and V (EXT2)
Usual Care Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)

Participant Flow for 5 periods

Period 1:   Period I - Placebo Run-in (Base)
    MK-0873 0.75 mg Base Study     MK-0873 1.25 mg Base Study     MK-0873 2.5 mg Base Study     Placebo Base Study     MK-0873 2.5 mg + Usual Care     Usual Care  
STARTED     150     148     153     153     0     0  
COMPLETED     150     148     153     153     0     0  
NOT COMPLETED     0     0     0     0     0     0  

Period 2:   Period II - 12-week Treatment (Base)
    MK-0873 0.75 mg Base Study     MK-0873 1.25 mg Base Study     MK-0873 2.5 mg Base Study     Placebo Base Study     MK-0873 2.5 mg + Usual Care     Usual Care  
STARTED     150     148     153     153     0     0  
COMPLETED     127     133     135     131     0     0  
NOT COMPLETED     23     15     18     22     0     0  
Clinical adverse experience                 11                 4                 9                 9                 0                 0  
Laboratory adverse experience                 1                 1                 0                 0                 0                 0  
Other reasons                 11                 10                 9                 13                 0                 0  

Period 3:   Period III - Blinded Extension (EXT1)
    MK-0873 0.75 mg Base Study     MK-0873 1.25 mg Base Study     MK-0873 2.5 mg Base Study     Placebo Base Study     MK-0873 2.5 mg + Usual Care     Usual Care  
STARTED     0     0     317 [1]   107 [2]   0     0  
COMPLETED     0     0     235     82     0     0  
NOT COMPLETED     0     0     82     25     0     0  
Site terminated                 0                 0                 57                 20                 0                 0  
Clinical adverse experience                 0                 0                 11                 1                 0                 0  
Laboratory adverse experience                 0                 0                 0                 1                 0                 0  
Other reasons                 0                 0                 14                 3                 0                 0  
[1] Includes all MK-0873 participants from Period II. Not all eligible participants entered EXT1
[2] Not all eligible participants entered EXT1

Period 4:   Period IV - Open-label Extension (EXT2)
    MK-0873 0.75 mg Base Study     MK-0873 1.25 mg Base Study     MK-0873 2.5 mg Base Study     Placebo Base Study     MK-0873 2.5 mg + Usual Care     Usual Care  
STARTED     0     0     0     0     187 [1]   71 [2]
COMPLETED     0     0     0     0     8     3  
NOT COMPLETED     0     0     0     0     179     68  
Site terminated                 0                 0                 0                 0                 169                 68  
Clinical adverse experience                 0                 0                 0                 0                 3                 0  
Laboratory adverse experience                 0                 0                 0                 0                 1                 0  
Other reasons                 0                 0                 0                 0                 6                 0  
[1] Includes participants from Period III. Not all eligible participants entered EXT2
[2] Includes paricipants from Period III. Not all eligible participants entered EXT2

Period 5:   Period V - Open-label Extension (EXT2)
    MK-0873 0.75 mg Base Study     MK-0873 1.25 mg Base Study     MK-0873 2.5 mg Base Study     Placebo Base Study     MK-0873 2.5 mg + Usual Care     Usual Care  
STARTED     0     0     0     0     7 [1]   2 [1]
COMPLETED     0     0     0     0     0     0  
NOT COMPLETED     0     0     0     0     7     2  
Site terminated                 0                 0                 0                 0                 7                 2  
[1] Not all participants who completed Period IV entered Period V



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MK-0873 0.75 mg Base Study 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)
MK-0873 1.25 mg Base Study 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)
MK-0873 2.5 mg Base Study 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)
Placebo Base Study 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)
Total Total of all reporting groups

Baseline Measures
    MK-0873 0.75 mg Base Study     MK-0873 1.25 mg Base Study     MK-0873 2.5 mg Base Study     Placebo Base Study     Total  
Number of Participants  
[units: participants]
  150     148     153     153     604  
Age, Customized [1]
[units: participants]
  150     148     153     153     604  
Gender  
[units: participants]
         
Female     36     45     45     41     167  
Male     114     103     108     112     437  
[1] Number of Participants Between 42 and 77 Years of Age



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Pre-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Pre-dose at Baseline and Treatment Weeks 8, 10 and 12 ]

2.  Secondary:   Change From Baseline in Overall Daytime Symptoms Score   [ Time Frame: Baseline and Treatment Weeks 8, 10 and 12 ]

3.  Secondary:   Change From Baseline in Total Daily Beta-agonist Use   [ Time Frame: Baseline and Treatment Weeks 8, 10 and 12 ]

4.  Secondary:   Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Response   [ Time Frame: Baseline and Treatment Weeks 8 and 12 ]

5.  Secondary:   Transition Dyspnea Index (TDI) Focal Score   [ Time Frame: Baseline and Treatment Week 12 ]

6.  Secondary:   Change From Baseline in Shortness of Breath Questionnaire (SOBQ) Response   [ Time Frame: Baseline and Treatment Weeks 8 and 12 ]

7.  Secondary:   Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation   [ Time Frame: Baseline through Treatment Week 12 ]

8.  Secondary:   Change From Baseline in Predose (Trough) Forced Vital Capacity (FVC)   [ Time Frame: Predose at Baseline and Treatment Weeks 8, 10 and 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00132730     History of Changes
Other Study ID Numbers: 0873-005, 2005_015
Study First Received: August 3, 2005
Results First Received: March 17, 2014
Last Updated: April 25, 2014
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos