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

Osteoarthritis of the Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01619839
• Other study ID #: 12-181-04
• Status: Completed
• Phase: Phase 2
• Start date: June 2012
• Est. completion date: September 2013

Study information

• Verified date: July 2021
• Source: Nektar Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• NKTR-181

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

Locations

Country	Name	City	State
United States	Investigator Site - Austin	Austin	Texas
United States	Investigator Site - Berlin	Berlin	New Jersey
United States	Investigator Site - Brockton	Brockton	Massachusetts
United States	Investigator Site - Charleston	Charleston	South Carolina
United States	Investigator Site - Cincinnati	Cincinnati	Ohio
United States	Investigator Site - Coral Gables	Coral Gables	Florida
United States	Investigator Site - Dallas	Dallas	Texas
United States	Investigator Site - Duncansville	Duncansville	Pennsylvania
United States	Investigator Site - Englewood	Englewood	New Jersey
United States	Investigator Site - Evansville	Evansville	Indiana
United States	Investigator Site - Fort Meyers	Fort Myers	Florida
United States	Investigator Site - Garden Grove	Garden Grove	California
United States	Investigator Site - Greensboro	Greensboro	North Carolina
United States	Investigator Site - Kansas City	Kansas City	Missouri
United States	Investigator Site - Kenosha	Kenosha	Wisconsin
United States	Investigator Site - Las Vegas	Las Vegas	Nevada
United States	Investigator Site - Las Vegas	Las Vegas	Nevada
United States	Investigator Site - Louisville	Louisville	Kentucky
United States	Investigator Site - Mobile	Mobile	Alabama
United States	Investigator Site - Oklahoma City	Oklahoma City	Oklahoma
United States	Investigator Site - Omaha	Omaha	Nebraska
United States	Investigator Site - Pembroke Pines	Pembroke Pines	Florida
United States	Investigator Site - Philadelphia	Philadelphia	Pennsylvania
United States	Investigator Site - Salt Lake City	Salt Lake City	Utah
United States	Investigator Site - San Antonio	San Antonio	Texas
United States	Investigator Site - San Antonio	San Antonio	Texas
United States	Investigator Site - San Diego	San Diego	California
United States	Investigator Site - Tuscon	Tucson	Arizona
United States	Investigator Site - Walnut Creek	Walnut Creek	California
United States	Investigator Site - West Palm Beach	West Palm Beach	Florida
United States	Investigator Site - Westlake Village	Westlake Village	California
United States	Investigator Site - Weston	Weston	Florida
United States	Investigator Site - Wichita	Wichita	Kansas
United States	Investigator Site - Worcester	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Nektar Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Mean Change From Baseline Pain Score to Pain Score at the End of the Double-blind Randomized Treatment Period.	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).	Baseline and Visit 10 (day 69)
Secondary	Time to Discontinuation During the Double-blind Randomized Treatment Period for Any Reason	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.	Randomization Treatment period is 24 days