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Completed

NCT Number: NCT01619839

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

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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigator Site - Mobile, Mobile, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NKTR-181

Drug

Placebo

Drug

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

Primary outcomes

  1. 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)

    The first phase of this trial involved an open-label titration period where patients were given NKTR-181 at increasing doses up to a maximum of 400 mg twice daily until adequate pain control was achieved. Patients achieving adequate pain control were then progressed to the second phase of the trial where patients were randomized in a 1:1 ratio to receive either placebo or their tolerable dose level of NKTR-181.

    All efficacy data for NKTR-181 patients was combined into one group regardless of tolerable dose level. For this outcome, the subjects had to rate their worst pain intensity during the past 4 hours from 0 to 10 on an 11-point scale, where 0 represented one end of the continuum (i.e., no pain) and 10 represented the other extreme of pain intensity (i.e., worst pain imaginable).

Secondary outcomes

  1. Time to Discontinuation During the Double-blind Randomized Treatment Period for Any Reason

    Time frame: Randomization Treatment period is 24 days

    The first phase of this trial involved an open-label titration period where patients were given NKTR-181 at increasing doses up to a maximum of 400 mg twice daily until adequate pain control was achieved. Patients achieving adequate pain control were then progressed to the second phase of the trial where patients were randomized in a 1:1 ratio to receive either placebo or their tolerable dose level of NKTR-181.

    All efficacy data for NKTR-181 patients was combined into one group regardless of tolerable dose level.

Sponsors and collaborators

Lead sponsor

Nektar Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 14, 2012
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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