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

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis of the Knee	Drug: NKTR-181 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain Osteoarthritis

U.S. FDA Resources

Further study details as provided by Nektar Therapeutics:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to discontinuation during the double-blind Randomized Treatment Period for any reason [ Time Frame: Randomization Treatment period is 24 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	June 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 100 mg NKTR-181	Drug: NKTR-181 100, 200, 300, and 400 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days
Experimental: 200 mg NKTR-181	Drug: NKTR-181 100, 200, 300, and 400 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days
Experimental: 300 mg NKTR-181	Drug: NKTR-181 100, 200, 300, and 400 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days
Experimental: 400 mg NKTR-181	Drug: NKTR-181 100, 200, 300, and 400 mg of NKTR-181 in tablet form, BID. Dosing to occur at Titration period up to 30 days and at Randomization period up to 24 days
Placebo Comparator: Placebo	Drug: Placebo Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619839

Contacts

Contact: Robert Medve, MD	415.482.5300	rmedve@nektar.com
Contact: Shane Smith	415.482.5300	ssmith@nektar.com

Show 34 Study Locations

Sponsors and Collaborators

Nektar Therapeutics

Investigators

Study Director:

Robert Medve, MD

Nektar Therapeutics

More Information

No publications provided

Responsible Party:	Nektar Therapeutics
ClinicalTrials.gov Identifier:	NCT01619839 History of Changes
Other Study ID Numbers:	12-181-04
Study First Received:	June 12, 2012
Last Updated:	May 3, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Nektar Therapeutics:

Nektar
NKTR-181

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis

Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013