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Long-Term Study of the Effects of Navarixin (SCH 527123, MK-7123) in Participants With Moderate to Severe COPD (MK-7123-019)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01006616
First received: October 1, 2009
Last updated: April 24, 2015
Last verified: April 2015
Results First Received: October 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: COPD
Interventions: Drug: Navarixin
Drug: Placebo
Drug: Rescue medication

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Navarixin 10 mg Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally once daily (QD) for up to 2 years
Navarixin 30 mg Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
Navarixin 50 mg Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
Placebo Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years

Participant Flow for 2 periods

Period 1:   Period 1 (6 Months)
    Navarixin 10 mg   Navarixin 30 mg   Navarixin 50 mg   Placebo
STARTED   152   156   153   155 
Treated   152   156   152   154 
COMPLETED   126   102   102   128 
NOT COMPLETED   26   54   51   27 
Adverse Event                10                31                37                9 
Lack of Efficacy                3                4                0                4 
Lost to Follow-up                0                0                1                0 
Withdrew, Reason Unrelated to Treatment                6                5                2                3 
Withdrew, Reason Related to Treatment                0                3                1                2 
Withdrawal by Subject                2                2                2                0 
Did Not Meet Protocol Eligibility                5                7                5                5 
Noncompliance With Protocol                0                2                2                3 
Not Treated                0                0                1                1 

Period 2:   Period 2 (18 Months)
    Navarixin 10 mg   Navarixin 30 mg   Navarixin 50 mg   Placebo
STARTED   75 [1]   63 [1]   55 [1]   82 [1] 
Treated   75   63   55   82 
COMPLETED   0   0   0   0 
NOT COMPLETED   75   63   55   82 
Adverse Event                6                6                6                4 
Lack of Efficacy                0                0                1                2 
Lost to Follow-up                2                0                0                0 
Withdrew, Reason Unrelated to Treatment                3                0                3                2 
Withdrew, Reason Related to Treatment                0                6                1                2 
Withdrawal by Subject                1                4                0                1 
Noncompliance With Protocol                0                1                0                1 
Study Terminated                63                46                44                70 
[1] Period 2 was optional. Not all participants completing Period 1 continued into Period 2.



  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.
Baseline Analysis Population consists of all treated participants (1 participant in the Navarixin 50 mg group and 1 participant in the Placebo group did not receive study drug).

Reporting Groups
  Description
Navarixin 10 mg Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
Navarixin 30 mg Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
Navarixin 50 mg Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
Placebo Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
Total Total of all reporting groups

Baseline Measures
   Navarixin 10 mg   Navarixin 30 mg   Navarixin 50 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 152   156   152   154   614 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.7  (6.9)   63.2  (7.4)   61.3  (7.5)   63.3  (7.2)   62.9  (7.3) 
Gender 
[Units: Participants]
         
Female   28   52   50   46   176 
Male   124   104   102   108   438 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (Period 1)   [ Time Frame: Baseline and Week 26 ]

2.  Primary:   Percentage of Participants With an Adverse Event (AE) Related to a Blood Absolute Neutrophil Count (ANC) of Less Than 1.5x10^9 Cells/L   [ Time Frame: Up to 104 weeks ]

3.  Secondary:   Change From Baseline in Post-bronchodilator FEV1 (Period 2)   [ Time Frame: Baseline and Week 52, Week 104 ]

4.  Secondary:   Number of Participants With a Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation   [ Time Frame: Up to 26 , 52 and 104 weeks ]

5.  Secondary:   Percentage of Participants With a Moderate to Severe COPD Exacerbation   [ Time Frame: Up to 26, 52 and 104 weeks ]

6.  Secondary:   Total Exacerbations of Chronic Pulmonary Disease Tool-Patient-Recorded Outcome (EXACT-PRO) Questionnaire Score   [ Time Frame: At 26, 52 and 104 weeks ]

7.  Secondary:   Induced Sputum Absolute Neutrophil Counts   [ Time Frame: Baseline, Week 26, Week 52, Week 104 ]

8.  Secondary:   Change From Baseline in St. George’s Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score   [ Time Frame: Baseline and Week 26, Week 52, Week 104 ]

9.  Secondary:   Change From Baseline in Distance Walked in 6 Minutes (6-Minute Walk Test)   [ Time Frame: Baseline and Week 26, Week 52, Week 104 ]

10.  Secondary:   Change From Baseline in Pre-bronchodilator FEV1   [ Time Frame: Baseline and Week 26, Week 52, Week 104 ]

11.  Secondary:   Change From Baseline in Forced Expiratory Flow During the Middle Half of the Forced Vital Capacity (FEF25%–75%) Test   [ Time Frame: Baseline and Week 26, Week 52, Week 104 ]

12.  Secondary:   Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)   [ Time Frame: Baseline and Week 26, Week 52, Week 104 ]

13.  Secondary:   Change From Baseline in Functional Residual Capacity (FRC)   [ Time Frame: Baseline and Week 26, Week 52, Week 104 ]

14.  Secondary:   Change From Baseline in Total Lung Capacity (TLC)   [ Time Frame: Baseline and Week 26, Week 52, Week 104 ]

15.  Secondary:   Change From Baseline in Inspiratory Capacity (IC)   [ Time Frame: Baseline and Week 26, Week 52, Week 104 ]

16.  Secondary:   Change From Baseline in Morning Peak Expiratory Flow (PEF)   [ Time Frame: Baseline and Week 26, Week 52, Week 104 ]

17.  Secondary:   Change From Baseline in Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Index Score   [ Time Frame: Baseline and Week 26, Week 52, Week 104 ]

18.  Secondary:   Change From Baseline in Modified Medical Research Council (MMRC) Dyspnea Score   [ Time Frame: Baseline and Week 26, Week 52, Week 104 ]

19.  Secondary:   Sputum Inflammatory Marker Levels: Interleukin 8 (IL-8)   [ Time Frame: Baseline, Week 26, Week 52, Week 104 ]

20.  Secondary:   Sputum Inflammatory Marker Levels: Myeloperoxidase (MPO)   [ Time Frame: Baseline, Week 26, Week 52, Week 104 ]

21.  Secondary:   Sputum Inflammatory Marker Levels: Sputum Neutrophil Elastase   [ Time Frame: Baseline, Week 26, Week 52, Week 104 ]

22.  Secondary:   Sputum Inflammatory Marker Levels: Matrix Metallopeptidase-9 (MMP-9)   [ Time Frame: Baseline, Week 26, Week 52, Week 104 ]

23.  Secondary:   Plasma Inflammatory Biomarker Levels: High-sensitivity C-reactive Protein (Hs-CRP)   [ Time Frame: Baseline, Week 26, Week 52, Week 104 ]

24.  Secondary:   Plasma Inflammatory Biomarker Levels: Fibrinogen   [ Time Frame: Baseline, Week 26, Week 52, Week 104 ]

25.  Secondary:   Plasma Inflammatory Biomarker Levels: Myeloperoxidase (MPO)   [ Time Frame: Baseline, Week 26, Week 52, Week 104 ]

26.  Secondary:   Plasma Inflammatory Biomarker Levels: Matrix Metallopeptidase-9 (MMP-9)   [ Time Frame: Baseline, Week 26, Week 52, Week 104 ]

27.  Secondary:   Plasma Inflammatory Biomarker Levels: Plasma Neutrophil Elastase   [ Time Frame: Baseline, Week 26, Week 52, Week 104 ]

28.  Secondary:   Plasma Inflammatory Biomarker Levels: Epithelial Cell-Derived Neutrophil Activating Peptide 78 (ENA-78)   [ Time Frame: Baseline, Week 26, Week 52, Week 104 ]

29.  Secondary:   Change From Baseline in Pre- and Post-6-Minute-Walk-Test Borg Scale Score   [ Time Frame: Baseline and Week 26, Week 52, Week 104 ]

30.  Secondary:   Change From Baseline in Percent of Arterial Oxygen Saturation Measured by Pulse Oximetry Before and After the 6-Minute Walk Test   [ Time Frame: Baseline and Week 26, Week 52, Week 104 ]

31.  Secondary:   Percentage of Participants Who Experienced an AE Related to Respiratory Infection   [ Time Frame: Up to 26 , 52 and 104 weeks ]

32.  Secondary:   Percentage of Participants Who Experienced an AE Related to Any Type of Infection   [ Time Frame: Up to 26 , 52 and 104 weeks ]


  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
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  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


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01006616     History of Changes
Other Study ID Numbers: P05575
2008-003780-38 ( EudraCT Number )
P05575 ( Other Identifier: Merck Research Laboratories )
Study First Received: October 1, 2009
Results First Received: October 2, 2014
Last Updated: April 24, 2015
Health Authority: Canada: Health Canada