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

June 12, 2012
August 14, 2014
June 2012
August 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01619839 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis of the Knee
  • Drug: 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
  • 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.
    Intervention: 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.
    Intervention: 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
    Intervention: 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
    Intervention: 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
213
September 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01619839
12-181-04
No
Nektar Therapeutics
Nektar Therapeutics
Not Provided
Study Director: Ivan Gergel, MD Nektar Therapeutics
Nektar Therapeutics
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP