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
1 other identifier
interventional
296
1 country
34
Brief Summary
NKTR-181 is being developed as an analgesic compound for the treatment of moderate to severe chronic pain - active as a mu agonist, but with inherent molecular properties designed to provide a unique clinical profile, including most notably, reduced CNS side effects and an attenuated attractiveness as a target of abuse.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2012
Shorter than P25 for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 12, 2012
CompletedFirst Posted
Study publicly available on registry
June 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
August 2, 2021
CompletedAugust 2, 2021
July 1, 2021
1.2 years
June 12, 2012
June 14, 2021
July 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Mean Change From Baseline Pain Score to Pain Score at the End of the Double-blind Randomized Treatment Period.
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)
Secondary Outcomes (1)
Time to Discontinuation During the Double-blind Randomized Treatment Period for Any Reason
Randomization Treatment period is 24 days
Study Arms (5)
100 mg NKTR-181
EXPERIMENTAL100 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.
200 mg NKTR-181
EXPERIMENTAL200 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.
300 mg NKTR-181
EXPERIMENTAL300 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
400 mg NKTR-181
EXPERIMENTAL400 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
Placebo
PLACEBO COMPARATORPlacebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Investigator Site - Mobile
Mobile, Alabama, 36608, United States
Investigator Site - Tuscon
Tucson, Arizona, 85704, United States
Investigator Site - Garden Grove
Garden Grove, California, 92844, United States
Investigator Site - San Diego
San Diego, California, 92103, United States
Investigator Site - Walnut Creek
Walnut Creek, California, 94598, United States
Investigator Site - Westlake Village
Westlake Village, California, 91361, United States
Investigator Site - Coral Gables
Coral Gables, Florida, 33134, United States
Investigator Site - Fort Meyers
Fort Myers, Florida, 33916, United States
Investigator Site - Pembroke Pines
Pembroke Pines, Florida, 33028, United States
Investigator Site - West Palm Beach
West Palm Beach, Florida, 33409, United States
Investigator Site - Weston
Weston, Florida, 33331, United States
Investigator Site - Evansville
Evansville, Indiana, 47714, United States
Investigator Site - Wichita
Wichita, Kansas, 67207, United States
Investigator Site - Louisville
Louisville, Kentucky, 40213, United States
Investigator Site - Brockton
Brockton, Massachusetts, 02301, United States
Investigator Site - Worcester
Worcester, Massachusetts, 01605, United States
Investigator Site - Kansas City
Kansas City, Missouri, 64114, United States
Investigator Site - Omaha
Omaha, Nebraska, 68134, United States
Investigator Site - Las Vegas
Las Vegas, Nevada, 89102, United States
Investigator Site - Las Vegas
Las Vegas, Nevada, 89119, United States
Investigator Site - Berlin
Berlin, New Jersey, 08009, United States
Investigator Site - Englewood
Englewood, New Jersey, 07631, United States
Investigator Site - Greensboro
Greensboro, North Carolina, 27410, United States
Investigator Site - Cincinnati
Cincinnati, Ohio, 45219, United States
Investigator Site - Oklahoma City
Oklahoma City, Oklahoma, 73109, United States
Investigator Site - Duncansville
Duncansville, Pennsylvania, 16635, United States
Investigator Site - Philadelphia
Philadelphia, Pennsylvania, 19139, United States
Investigator Site - Charleston
Charleston, South Carolina, 29406, United States
Investigator Site - Austin
Austin, Texas, 78705, United States
Investigator Site - Dallas
Dallas, Texas, 75231, United States
Investigator Site - San Antonio
San Antonio, Texas, 78205, United States
Investigator Site - San Antonio
San Antonio, Texas, 78209, United States
Investigator Site - Salt Lake City
Salt Lake City, Utah, 84106, United States
Investigator Site - Kenosha
Kenosha, Wisconsin, 53142, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Nektar Therapeutics
Study Officials
- STUDY DIRECTOR
Study Director
Nektar Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2012
First Posted
June 14, 2012
Study Start
June 1, 2012
Primary Completion
August 1, 2013
Study Completion
September 1, 2013
Last Updated
August 2, 2021
Results First Posted
August 2, 2021
Record last verified: 2021-07