A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: NKTR-181; Placebo
Intervention description: Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 296.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nektar; NKTR-181

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.
    

Eligibility criteria:

        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.