- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01619839
A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain
A Phase 2, Enriched-Enrollment, Randomized-Withdrawal, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Tolerability, and Safety of NKTR-181 in Opioid-Naïve Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Mobile, Alabama, United States, 36608
- Investigator Site - Mobile
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Arizona
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Tucson, Arizona, United States, 85704
- Investigator Site - Tuscon
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California
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Garden Grove, California, United States, 92844
- Investigator Site - Garden Grove
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San Diego, California, United States, 92103
- Investigator Site - San Diego
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Walnut Creek, California, United States, 94598
- Investigator Site - Walnut Creek
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Westlake Village, California, United States, 91361
- Investigator Site - Westlake Village
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Florida
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Coral Gables, Florida, United States, 33134
- Investigator Site - Coral Gables
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Fort Myers, Florida, United States, 33916
- Investigator Site - Fort Meyers
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Pembroke Pines, Florida, United States, 33028
- Investigator Site - Pembroke Pines
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West Palm Beach, Florida, United States, 33409
- Investigator Site - West Palm Beach
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Weston, Florida, United States, 33331
- Investigator Site - Weston
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Indiana
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Evansville, Indiana, United States, 47714
- Investigator Site - Evansville
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Kansas
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Wichita, Kansas, United States, 67207
- Investigator Site - Wichita
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Kentucky
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Louisville, Kentucky, United States, 40213
- Investigator Site - Louisville
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Massachusetts
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Brockton, Massachusetts, United States, 02301
- Investigator Site - Brockton
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Worcester, Massachusetts, United States, 01605
- Investigator Site - Worcester
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Missouri
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Kansas City, Missouri, United States, 64114
- Investigator Site - Kansas City
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Nebraska
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Omaha, Nebraska, United States, 68134
- Investigator Site - Omaha
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Nevada
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Las Vegas, Nevada, United States, 89102
- Investigator Site - Las Vegas
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Las Vegas, Nevada, United States, 89119
- Investigator Site - Las Vegas
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New Jersey
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Berlin, New Jersey, United States, 08009
- Investigator Site - Berlin
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Englewood, New Jersey, United States, 07631
- Investigator Site - Englewood
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North Carolina
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Greensboro, North Carolina, United States, 27410
- Investigator Site - Greensboro
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Ohio
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Cincinnati, Ohio, United States, 45219
- Investigator Site - Cincinnati
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73109
- Investigator Site - Oklahoma City
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Investigator Site - Duncansville
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Philadelphia, Pennsylvania, United States, 19139
- Investigator Site - Philadelphia
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South Carolina
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Charleston, South Carolina, United States, 29406
- Investigator Site - Charleston
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Texas
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Austin, Texas, United States, 78705
- Investigator Site - Austin
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Dallas, Texas, United States, 75231
- Investigator Site - Dallas
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San Antonio, Texas, United States, 78205
- Investigator Site - San Antonio
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San Antonio, Texas, United States, 78209
- Investigator Site - San Antonio
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Utah
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Salt Lake City, Utah, United States, 84106
- Investigator Site - Salt Lake City
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Wisconsin
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Kenosha, Wisconsin, United States, 53142
- Investigator Site - Kenosha
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Willing and able to give written informed consent;
- Willing and able to understand the study procedures, and comply with all study procedures;
- Females or males, age ≥ 18 years old;
- Body mass index 18-39, inclusive;
- In good general health;
- Clinical diagnosis of OA in one or both knees;
- Have been on a stable regimen of pain medication for the management of OA knee pain;
- Not experiencing adequate pain relief with their current dosing regimen;
- Women of childbearing potential (WCBP) must agree to use highly effective methods of birth control. Male subjects must agree to use contraception.
Exclusion Criteria:
- Females who are pregnant or lactating;
- Known history of hypersensitivity, intolerance, or allergy to opioids;
- Diagnosed as having any chronic pain symptom that in the Investigator's opinion would interfere with the assessment of pain and other symptoms of OA;
- Presence of any medical condition that would preclude study participation in the opinion of the investigator;
- Clinically significant abnormalities of vital signs or clinical laboratory results;
- Clinically significant electrocardiographic abnormalities;
- Received systemic corticosteroids within 30 days prior to signing the consent form;
- Subjects who are known or suspected to be currently abusing alcohol or drugs;
- Positive urine drug screen, or alcohol breath test during Screening Period testing;
- Positive serology for the surface antigen of Hepatitis B (HBsAg) or Hepatitis C (anti-HCV) during Screening Period testing;
- Known to be human immunodeficiency virus (HIV) positive;
- Donation of blood or plasma within 30 days prior to signing the consent form;
- Participation in another drug or biologic study within 30 days prior to signing the consent form;
- Any other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for participation in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 100 mg NKTR-181
100 mg of NKTR-181 in tablet form, BID.
Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days.
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Experimental: 200 mg NKTR-181
200 mg of NKTR-181 in tablet form, BID.
Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days.
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Experimental: 300 mg NKTR-181
300 mg of NKTR-181 in tablet form, BID.
Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days
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Experimental: 400 mg NKTR-181
400 mg of NKTR-181 in tablet form, BID.
Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days
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Placebo Comparator: Placebo
Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181.
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Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The Mean Change From Baseline Pain Score to Pain Score at the End of the Double-blind Randomized Treatment Period.
Time Frame: Baseline and Visit 10 (day 69)
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The first phase of this trial involved an open-label titration period where patients were given NKTR-181 at increasing doses up to a maximum of 400 mg twice daily until adequate pain control was achieved. Patients achieving adequate pain control were then progressed to the second phase of the trial where patients were randomized in a 1:1 ratio to receive either placebo or their tolerable dose level of NKTR-181. All efficacy data for NKTR-181 patients was combined into one group regardless of tolerable dose level. For this outcome, the subjects had to rate their worst pain intensity during the past 4 hours from 0 to 10 on an 11-point scale, where 0 represented one end of the continuum (i.e., no pain) and 10 represented the other extreme of pain intensity (i.e., worst pain imaginable). |
Baseline and Visit 10 (day 69)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Discontinuation During the Double-blind Randomized Treatment Period for Any Reason
Time Frame: Randomization Treatment period is 24 days
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The first phase of this trial involved an open-label titration period where patients were given NKTR-181 at increasing doses up to a maximum of 400 mg twice daily until adequate pain control was achieved. Patients achieving adequate pain control were then progressed to the second phase of the trial where patients were randomized in a 1:1 ratio to receive either placebo or their tolerable dose level of NKTR-181. All efficacy data for NKTR-181 patients was combined into one group regardless of tolerable dose level. |
Randomization Treatment period is 24 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-181-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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