A Four-Week Multicenter Study Evaluating the Safety and Efficacy of AF-219 in Subjects With Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01554579
First received: March 12, 2012
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to assess the efficacy of a single dose level of AF-219 in subjects with moderate to severe pain associated with osteoarthritis (OA) of the knee compared with placebo after 4 weeks of treatment.

The study will also assess the safety and tolerability, changes in physical function, stiffness, global assessment of OA, treatment response and health outcomes.


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: AF-219
Drug: Sugar Pill
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

Resource links provided by NLM:


Further study details as provided by Afferent Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • The primary efficacy endpoint of this study is change from Baseline (Week 4 to Baseline) of the weekly average daily NPRS (average pain) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WOMAC Scores [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Daily Pain Scores [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Osteoarthritis [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Patient's and Clinician's Global Impression of Change [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Rescue medication usage [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Withdrawal for lack of efficacy [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Enrollment: 190
Study Start Date: March 2012
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar pill Drug: Sugar Pill
Placebo
Experimental: AF-219 Drug: AF-219
BID

Detailed Description:

Subjects who satisfy entry criteria at Screening will enter the Washout Phase, discontinuing their current nonsteroidal anti-inflammatory drug (NSAID) therapy.

Up to 220 subjects who fulfill flare (and other entry) criteria will be randomized to AF-219 or placebo.

Subjects will complete Treatment Visits 1, 2, 3, and 4 weeks after starting study drug. At each Treatment Visit, subjects will undergo efficacy assessments and safety procedures. During the Washout and Treatment Phases subjects will complete the 'average pain' Numeric Pain Rating Scale (NPRS) and count of rescue medication used for the preceding 24 hours.

Subjects will return 2 weeks after their last Treatment Visit (for a Follow-Up Visit).

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women
  • Women of child bearing potential must not be pregnant during the study and must use two forms of birth control
  • Men and their female partners must use two forms of birth control
  • Clinical and radiographic evidence of chronic knee osteoarthritis
  • Minimum pain at Screening and during Washout
  • Ambulatory
  • Have provided written informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554579

  Hide Study Locations
Locations
United States, Arizona
Afferent Investigative Site
Phoenix, Arizona, United States, 85027
Afferent Investigative Site
Phoenix, Arizona, United States, 85018
United States, California
Afferent Investigative Site
San Diego, California, United States, 92108
United States, Florida
Afferent Investigative Site
Clearwater, Florida, United States, 33756
Afferent Investigative Site
Orlando, Florida, United States, 32806
Afferent Investigative Site
Pinellas Park, Florida, United States, 33781
United States, Georgia
Afferent Investigative Site
Atlanta, Georgia, United States, 30329
United States, Kansas
Afferent Investigative Site
Wichita, Kansas, United States, 67203
United States, Massachusetts
Afferent Investigative Site
New Bedford, Massachusetts, United States, 02740
Afferent Investigative Site
Watertown, Massachusetts, United States, 02472
United States, Michigan
Afferent Investigative Site
Troy, Michigan, United States, 48098
United States, Mississippi
Afferent Investigative Site
Olive Branch, Mississippi, United States, 38654
United States, Missouri
Afferent Investigative Site
Hazelwood, Missouri, United States, 63042
Afferent Investigative Site
St. Louis, Missouri, United States, 63141
United States, New Mexico
Afferent Investigative Site
Albuquerque, New Mexico, United States, 87102
United States, North Carolina
Afferent Investigative Site
Asheville, North Carolina, United States, 28803
Afferent Investigative Site
Greensboro, North Carolina, United States, 27408
Afferent Investigative Site
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Afferent Investigative Site
Cincinnati, Ohio, United States, 45219
Afferent Investigative Site
Toledo, Ohio, United States, 43623
United States, Oregon
Afferent Investigative Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
Afferent Investigative Site
Duncansville, Pennsylvania, United States, 16635
United States, Rhode Island
Afferent Investigative Site
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Afferent Investigative Site
Greer, South Carolina, United States, 29650
Afferent Investigative Site
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
Afferent Investigative Site
Austin, Texas, United States, 78705
Afferent Investigative Site
Dallas, Texas, United States, 75231
Afferent Investigative Site
Houston, Texas, United States, 77062
Afferent Investigative Site
San Antonio, Texas, United States, 78209
Afferent Investigative Site
San Antonio, Texas, United States, 78229
United States, Utah
Afferent Investigative Site
Clinton, Utah, United States, 84015
United States, Virginia
Afferent Investigative Site
Roanoke, Virginia, United States, 24018
United States, Washington
Afferent Investigative Site
Renton, Washington, United States, 98057
United States, Wisconsin
Afferent Investigative Site
Kenosha, Wisconsin, United States, 53142
Sponsors and Collaborators
Afferent Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01554579     History of Changes
Other Study ID Numbers: AF219-004
Study First Received: March 12, 2012
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 22, 2014