Ignite Creation Date:
2024-05-05 @ 9:59 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01006616
Status:
TERMINATED
Last Update Posted:
2019-01-02
First Post:
2009-10-01
Brief Title:
Long-Term Study of the Effects of Navarixin SCH 527123 MK-7123 in Participants With Moderate to Severe COPD MK-7123-019
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A 2-Year Dose Range-Finding Adaptive-Design Study of the Effects of SCH 527123 in Subjects With Moderate to Severe COPD
Status:
TERMINATED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neutrophils are thought to play an important role in the pathophysiology of chronic obstructive pulmonary disease COPD Navarixin SCH 527123 MK-7123 is an antagonist of the cysteine-X-cysteine chemokine receptor 2 CXCR2 and is thought to reduce neutrophil migration to the diseased lung It is theorized that reducing neutrophil migration to the diseased lung will improve a participants symptoms and the natural history of the disease
The study will consist of a 2-week screening period followed by a 2-year 104-week double-blind treatment period The 2-year Treatment Period will be made up of two phases a 26-week 6-month dose range-finding phase with 3 active arms and 1 placebo arm Period 1 followed by a 78-week 18-month long-term safety and efficacy phase Period 2 Participants participating in the original 6-month study Period 1 may elect not to continue into the 18-month extension study Period 2
Hypothesis navarixin 50 mg or the highest remaining dose if the 50-mg dose is discontinued is superior to placebo with respect to improving airflow
The study will consist of a 2-week screening period followed by a 2-year 104-week double-blind treatment period The 2-year Treatment Period will be made up of two phases a 26-week 6-month dose range-finding phase with 3 active arms and 1 placebo arm Period 1 followed by a 78-week 18-month long-term safety and efficacy phase Period 2 Participants participating in the original 6-month study Period 1 may elect not to continue into the 18-month extension study Period 2
Hypothesis navarixin 50 mg or the highest remaining dose if the 50-mg dose is discontinued is superior to placebo with respect to improving airflow
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2008-003780-38 | EUDRACT_NUMBER | None | None |
| P05575 | OTHER | Merck Research Laboratories | None |