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

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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
33
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175 Meadowbrook Lane
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175 Cross Keys Rd.
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4110 Center Point Dr.
Fort Myers, Florida 33916
239-936-4421
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1010 Carondelet Drive
Kaw, Missouri 64114
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3288 Illinois Avenue
Louisville East, Kentucky 40217
502-214-3990
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275 Alhambra Circle
Miami, Florida 33134
305-445-5637
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8144 Walnut Hill Lane
Northeast, Texas 75231
214-879-6737
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Pembroke Pines, Florida 33028
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1709 S Rock Rd
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Austin, Texas 78705
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Charleston, South Carolina 29406
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