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

NCT ID: NCT01619839

Last Updated: 2021-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-09-30

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.

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

100 mg NKTR-181

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.

Group Type: EXPERIMENTAL

NKTR-181

Intervention Type: DRUG

200 mg NKTR-181

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.

Group Type: EXPERIMENTAL

NKTR-181

Intervention Type: DRUG

300 mg NKTR-181

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

Group Type: EXPERIMENTAL

NKTR-181

Intervention Type: DRUG

400 mg NKTR-181

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

Group Type: EXPERIMENTAL

NKTR-181

Intervention Type: DRUG

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

NKTR-181

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nektar Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Nektar Therapeutics

Locations

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

Investigator Site - Duncansville

Duncansville, Pennsylvania, United States

Investigator Site - Philadelphia

Philadelphia, Pennsylvania, United States

Investigator Site - Charleston

Charleston, South Carolina, United States

Investigator Site - Austin

Austin, Texas, United States

Investigator Site - Dallas

Dallas, Texas, United States

Investigator Site - San Antonio

San Antonio, Texas, United States

Investigator Site - San Antonio

San Antonio, Texas, United States

Investigator Site - Salt Lake City

Salt Lake City, Utah, United States

Investigator Site - Kenosha

Kenosha, Wisconsin, United States

Countries

United States

Other Identifiers

12-181-04

Identifier Type: -

Identifier Source: org_study_id