EHMC IRB
Study #: |
E-12-466 |
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Principal Investigator: |
Dr. Jeffrey Gudin |
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Tel: 201-568-5250 |
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Study Coordinator: |
Mustafa Caylan |
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Tel: 201-894-3603 |
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Sponsor: |
Nektar Therapeutics |
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Study Title: |
A Phase 2, Enriched-Enrollment, Randomized-Withdrawal, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Tolerability, |
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and Safety of NKTR-181 in Opioid-Naïve Subjects with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee |
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Eligibility requirements: |
Patients who are at least 18 years old with a diagnosis of osteoarthritis of the knee for at least six months. Patients must be on a stable dose |
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of non-opioid pain medication (Ex. COX-2 selective inhibitor, NSAID, or acetaminophen. |
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Study objectives: |
To determine the effectiveness of NKTR-181 by comparing change in pain scores from baseline to the end of randomization period. |
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Summary of procedures: |
Eligible patients will record daily pain scores into an electronic diary. Patients will continue to take their normal non-opioid pain medication |
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and begin taking NKTR-181 in increasing increments until a stable and effective dose is reached, which may take up to 30 days. Patients who successfully |
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complete this initial phase will then be randomized 1:1 to receive the NKTR-181 vs. placebo. This randomized treatment phase will last up to 24 days. |
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Throughout the study, patients continue the regular, non-opioid medication that they were on pre-study. After the end of the randomized treatment |
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period, the patient will receive two follow-up phone calls - one at 7 days post treatment and one at 30 days post treatment. |
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Medical Services