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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT01619839
First received: June 12, 2012
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: NKTR-181
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Enriched-Enrollment, Randomized-Withdrawal, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Tolerability, and Safety of NKTR-181 in Opioid-Naïve Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by Nektar Therapeutics:

Primary Outcome Measures:
  • The mean change from Baseline Pain Score to pain score at the end of the double-blind Randomized Treatment Period. [ Time Frame: Baseline and Visit 10 (day 69) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to discontinuation during the double-blind Randomized Treatment Period for any reason [ Time Frame: Randomization Treatment period is 24 days ] [ Designated as safety issue: No ]

Enrollment: 213
Study Start Date: June 2012
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: NKTR-181
Experimental: 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.
Drug: NKTR-181
Experimental: 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
Drug: NKTR-181
Experimental: 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
Drug: NKTR-181
Placebo Comparator: Placebo
Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181.
Drug: Placebo
Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619839

  Hide Study Locations
Locations
United States, Alabama
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
United States, Arizona
Genova Clinical Research, Inc.
Tucson, Arizona, United States, 85704
United States, California
SC Clinical Research
Garden Grove, California, United States, 92844
San Diego, California, United States, 92103
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
Westlake Medical Research
Westlake Village, California, United States, 91361
United States, Florida
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
Clinical Physiology Associates
Fort Meyers, Florida, United States, 33916
Pines Clinical Research
Pembroke Pines, Florida, United States, 33028
Palm Beach Research
West Palm Beach, Florida, United States, 33409
Gold Coast Research, LLD
Weston, Florida, United States, 33331
United States, Indiana
Medisphere Medical Research
Evansville, Indiana, United States, 47714
United States, Kansas
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Kentucky
L-MARC Research Center
Louisville, Kentucky, United States, 40213
United States, Massachusetts
Beacon Clinical Research, LLC
Brockton, Massachusetts, United States, 02301
Worcester, Massachusetts, United States, 01605
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, Nebraska
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, Nevada
Clinical Research Consortium
Las Vegas, Nevada, United States, 89119
Clinical Research Consortium
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
Pain Center
Englewood, New Jersey, United States, 07631
United States, North Carolina
Triad Clinical Trials, LLD
Greensboro, North Carolina, United States, 27410
United States, Ohio
Sterling Research Group, Inc.
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73109
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
CRI Lifetree - Philadephia
Philadelphia, Pennsylvania, United States, 19139
United States, South Carolina
Pain Research of Charleston
Charleston, South Carolina, United States, 29406
United States, Texas
Premier Research Group - Austin
Austin, Texas, United States, 78705
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
San Antonio, Texas, United States, 78205
Quality Research Inc.
San Antonio, Texas, United States, 78209
United States, Utah
CRI Lifetree - Salt Lake City
Salt Lake City, Utah, United States, 84106
United States, Wisconsin
Clinical Investigation Specialists
Kenosha, Wisconsin, United States, 53142
Sponsors and Collaborators
Nektar Therapeutics
Investigators
Study Director: Ivan Gergel, MD Nektar Therapeutics
  More Information

No publications provided

Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT01619839     History of Changes
Other Study ID Numbers: 12-181-04
Study First Received: June 12, 2012
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Nektar Therapeutics:
Nektar
NKTR-181

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014