A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain
Osteoarthritis of the Knee
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Nektar, NKTR-181
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.
Sites / Locations
- Investigator Site - Mobile
- Investigator Site - Tuscon
- Investigator Site - Garden Grove
- Investigator Site - San Diego
- Investigator Site - Walnut Creek
- Investigator Site - Westlake Village
- Investigator Site - Coral Gables
- Investigator Site - Fort Meyers
- Investigator Site - Pembroke Pines
- Investigator Site - West Palm Beach
- Investigator Site - Weston
- Investigator Site - Evansville
- Investigator Site - Wichita
- Investigator Site - Louisville
- Investigator Site - Brockton
- Investigator Site - Worcester
- Investigator Site - Kansas City
- Investigator Site - Omaha
- Investigator Site - Las Vegas
- Investigator Site - Las Vegas
- Investigator Site - Berlin
- Investigator Site - Englewood
- Investigator Site - Greensboro
- Investigator Site - Cincinnati
- Investigator Site - Oklahoma City
- Investigator Site - Duncansville
- Investigator Site - Philadelphia
- Investigator Site - Charleston
- Investigator Site - Austin
- Investigator Site - Dallas
- Investigator Site - San Antonio
- Investigator Site - San Antonio
- Investigator Site - Salt Lake City
- Investigator Site - Kenosha
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
100 mg NKTR-181
200 mg NKTR-181
300 mg NKTR-181
400 mg NKTR-181
Placebo
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.
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.
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
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
Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181.