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

March 12, 2012
January 6, 2014
March 2012
September 2013   (final data collection date for primary outcome measure)
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 ]
The primary efficacy endpoint of this study is change from Baseline of Question #1 of the WOMAC Osteoarthritis Index pain subscale (walking pain) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01554579 on ClinicalTrials.gov Archive Site
  • 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 ]
  • WOMAC Scores [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
  • Daily Pain Scores [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
  • Patient Global Assessment of Osteoarthritis [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
  • Patient's and Clinician's Global Impression of Change [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
  • Rescue medication usage [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
  • Withdrawal for lack of efficacy [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
  • SF-36 [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Four-Week Multicenter Study Evaluating the Safety and Efficacy of AF-219 in Subjects With Osteoarthritis of the Knee
Not Provided

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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis of the Knee
  • Drug: AF-219
    BID
  • Drug: Sugar Pill
    Placebo
  • Placebo Comparator: Sugar pill
    Intervention: Drug: Sugar Pill
  • Experimental: AF-219
    Intervention: Drug: AF-219
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
December 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01554579
AF219-004
Yes
Afferent Pharmaceuticals, Inc.
Afferent Pharmaceuticals, Inc.
Not Provided
Not Provided
Afferent Pharmaceuticals, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP