A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain
Status: | Completed |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/19/2013 |
Start Date: | June 2012 |
End Date: | December 2013 |
Contact: | Robert Medve, MD |
Email: | rmedve@nektar.com |
Phone: | 415.482.5300 |
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.
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.
We found this trial at
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