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

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NKTR-181
Placebo
Sponsored by
Nektar Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Nektar, NKTR-181

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigator Site - Mobile
  • Investigator Site - Tuscon
  • Investigator Site - Garden Grove
  • Investigator Site - San Diego
  • Investigator Site - Walnut Creek
  • Investigator Site - Westlake Village
  • Investigator Site - Coral Gables
  • Investigator Site - Fort Meyers
  • Investigator Site - Pembroke Pines
  • Investigator Site - West Palm Beach
  • Investigator Site - Weston
  • Investigator Site - Evansville
  • Investigator Site - Wichita
  • Investigator Site - Louisville
  • Investigator Site - Brockton
  • Investigator Site - Worcester
  • Investigator Site - Kansas City
  • Investigator Site - Omaha
  • Investigator Site - Las Vegas
  • Investigator Site - Las Vegas
  • Investigator Site - Berlin
  • Investigator Site - Englewood
  • Investigator Site - Greensboro
  • Investigator Site - Cincinnati
  • Investigator Site - Oklahoma City
  • Investigator Site - Duncansville
  • Investigator Site - Philadelphia
  • Investigator Site - Charleston
  • Investigator Site - Austin
  • Investigator Site - Dallas
  • Investigator Site - San Antonio
  • Investigator Site - San Antonio
  • Investigator Site - Salt Lake City
  • Investigator Site - Kenosha

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

100 mg NKTR-181

200 mg NKTR-181

300 mg NKTR-181

400 mg NKTR-181

Placebo

Arm Description

100 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.

200 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.

300 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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
June 12, 2012
Last Updated
July 9, 2021
Sponsor
Nektar Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01619839
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nektar Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Nektar, NKTR-181

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
100 mg NKTR-181
Arm Type
Experimental
Arm Description
100 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.
Arm Title
200 mg NKTR-181
Arm Type
Experimental
Arm Description
200 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.
Arm Title
300 mg NKTR-181
Arm Type
Experimental
Arm Description
300 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
Arm Title
400 mg NKTR-181
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181.
Intervention Type
Drug
Intervention Name(s)
NKTR-181
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181
Primary Outcome Measure Information:
Title
The Mean Change From Baseline Pain Score to Pain Score at the End of the Double-blind Randomized Treatment Period.
Description
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).
Time Frame
Baseline and Visit 10 (day 69)
Secondary Outcome Measure Information:
Title
Time to Discontinuation During the Double-blind Randomized Treatment Period for Any Reason
Description
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.
Time Frame
Randomization Treatment period is 24 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Nektar Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Investigator Site - Mobile
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Investigator Site - Tuscon
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Investigator Site - Garden Grove
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Facility Name
Investigator Site - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Investigator Site - Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Investigator Site - Westlake Village
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Investigator Site - Coral Gables
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Investigator Site - Fort Meyers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Investigator Site - Pembroke Pines
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Investigator Site - West Palm Beach
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Investigator Site - Weston
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Investigator Site - Evansville
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Investigator Site - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Investigator Site - Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Investigator Site - Brockton
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Investigator Site - Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Investigator Site - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Investigator Site - Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Investigator Site - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Investigator Site - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Investigator Site - Berlin
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Investigator Site - Englewood
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Investigator Site - Greensboro
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
Investigator Site - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Investigator Site - Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Investigator Site - Duncansville
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Investigator Site - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Investigator Site - Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Investigator Site - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Investigator Site - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Investigator Site - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Investigator Site - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Investigator Site - Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Investigator Site - Kenosha
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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