A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis of the Knee

In brief

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.

Key facts

Study ID

NCT01619839

Run by

Nektar Therapeutics

People needed

296

Starts

2012-06-01

Expected to finish

2013-09-01

Last updated by the study team

2021-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Investigator Site - Mobile — Mobile, Alabama, United States
• Investigator Site - Tuscon — Tucson, Arizona, United States
• Investigator Site - Garden Grove — Garden Grove, California, United States
• Investigator Site - San Diego — San Diego, California, United States
• Investigator Site - Walnut Creek — Walnut Creek, California, United States
• Investigator Site - Westlake Village — Westlake Village, California, United States
• Investigator Site - Coral Gables — Coral Gables, Florida, United States
• Investigator Site - Fort Meyers — Fort Myers, Florida, United States
• Investigator Site - Pembroke Pines — Pembroke Pines, Florida, United States
• Investigator Site - West Palm Beach — West Palm Beach, Florida, United States
• Investigator Site - Weston — Weston, Florida, United States
• Investigator Site - Evansville — Evansville, Indiana, United States
• Investigator Site - Wichita — Wichita, Kansas, United States
• Investigator Site - Louisville — Louisville, Kentucky, United States
• Investigator Site - Brockton — Brockton, Massachusetts, United States
• Investigator Site - Worcester — Worcester, Massachusetts, United States
• Investigator Site - Kansas City — Kansas City, Missouri, United States
• Investigator Site - Omaha — Omaha, Nebraska, United States
• Investigator Site - Las Vegas — Las Vegas, Nevada, United States
• Investigator Site - Las Vegas — Las Vegas, Nevada, United States
• Investigator Site - Berlin — Berlin, New Jersey, United States
• Investigator Site - Englewood — Englewood, New Jersey, United States
• Investigator Site - Greensboro — Greensboro, North Carolina, United States
• Investigator Site - Cincinnati — Cincinnati, Ohio, United States
• Investigator Site - Oklahoma City — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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