Clinical trial NCT01619839: A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: Nektar
NKTR-181
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-06-14
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The Mean Change From Baseline Pain Score to Pain Score at the End of the Double-blind Randomized Treatment Period.
timeFrame: Baseline and Visit 10 (day 69)
Secondary outcomes:
measure: Time to Discontinuation During the Double-blind Randomized Treatment Period for Any Reason
timeFrame: Randomization Treatment period is 24 days
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Investigator Site - Mobile
state: Alabama
city: Tucson
country: United States
facility: Investigator Site - Tuscon
state: Arizona
city: Garden Grove
country: United States
facility: Investigator Site - Garden Grove
state: California
city: San Diego
country: United States
facility: Investigator Site - San Diego
state: California
city: Walnut Creek
country: United States
facility: Investigator Site - Walnut Creek
state: California
city: Westlake Village
country: United States
facility: Investigator Site - Westlake Village
state: California
city: Coral Gables
country: United States
facility: Investigator Site - Coral Gables
state: Florida
city: Fort Myers
country: United States
facility: Investigator Site - Fort Meyers
state: Florida
city: Pembroke Pines
country: United States
facility: Investigator Site - Pembroke Pines
state: Florida
city: West Palm Beach
country: United States
facility: Investigator Site - West Palm Beach
state: Florida
city: Weston
country: United States
facility: Investigator Site - Weston
state: Florida
city: Evansville
country: United States
facility: Investigator Site - Evansville
state: Indiana
city: Wichita
country: United States
facility: Investigator Site - Wichita
state: Kansas
city: Louisville
country: United States
facility: Investigator Site - Louisville
state: Kentucky
city: Brockton
country: United States
facility: Investigator Site - Brockton
state: Massachusetts
city: Worcester
country: United States
facility: Investigator Site - Worcester
state: Massachusetts
city: Kansas City
country: United States
facility: Investigator Site - Kansas City
state: Missouri
city: Omaha
country: United States
facility: Investigator Site - Omaha
state: Nebraska
city: Las Vegas
country: United States
facility: Investigator Site - Las Vegas
state: Nevada
city: Las Vegas
country: United States
facility: Investigator Site - Las Vegas
state: Nevada
city: Berlin
country: United States
facility: Investigator Site - Berlin
state: New Jersey
city: Englewood
country: United States
facility: Investigator Site - Englewood
state: New Jersey
city: Greensboro
country: United States
facility: Investigator Site - Greensboro
state: North Carolina
city: Cincinnati
country: United States
facility: Investigator Site - Cincinnati
state: Ohio
city: Oklahoma City
country: United States
facility: Investigator Site - Oklahoma City
state: Oklahoma
city: Duncansville
country: United States
facility: Investigator Site - Duncansville
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigator Site - Philadelphia
state: Pennsylvania
city: Charleston
country: United States
facility: Investigator Site - Charleston
state: South Carolina
city: Austin
country: United States
facility: Investigator Site - Austin
state: Texas
city: Dallas
country: United States
facility: Investigator Site - Dallas
state: Texas
city: San Antonio
country: United States
facility: Investigator Site - San Antonio
state: Texas
city: San Antonio
country: United States
facility: Investigator Site - San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Investigator Site - Salt Lake City
state: Utah
city: Kenosha
country: United States
facility: Investigator Site - Kenosha
state: Wisconsin
Study officials:
affiliation: Nektar Therapeutics
name: Study Director
role: STUDY_DIRECTOR
References: