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

This study is currently recruiting participants.
Verified March 2013 by Afferent Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01554579
First received: March 12, 2012
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  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:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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 ]

Estimated Enrollment: 220
Study Start Date: March 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554579

Contacts
Contact: Afferent Director, MD 650-286-1423

  Show 37 Study Locations
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: March 26, 2013
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 May 23, 2013