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

Nektar Therapeutics

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis of the Knee

Treatments: Drug: NKTR-181; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01619839

12-181-04

Details and patient eligibility

About

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.

Enrollment: 296 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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296 participants in 5 patient groups, including a placebo group

100 mg NKTR-181

Experimental group

Description:

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.

Treatment:

Drug: NKTR-181

200 mg NKTR-181

Experimental group

Description:

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.

Treatment:

Drug: NKTR-181

300 mg NKTR-181

Experimental group

Description:

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

Treatment:

Drug: NKTR-181

400 mg NKTR-181

Experimental group

Description:

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

Treatment:

Drug: NKTR-181

Placebo

Placebo Comparator group

Description:

Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181.

Treatment:

Drug: Placebo