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

Tracking Information

First Received Date ^ICMJE

March 12, 2012

Last Updated Date

March 26, 2013

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT01554579 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

Brief Summary

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.

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).

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Osteoarthritis of the Knee

Intervention ^ICMJE

Drug: AF-219
BID
Drug: Sugar Pill
Placebo

Study Arm (s)

Placebo Comparator: Sugar pill
Intervention: Drug: Sugar Pill
Experimental: AF-219
Intervention: Drug: AF-219

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

220

Estimated Completion Date

October 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Afferent Director, MD

650-286-1423

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01554579

Other Study ID Numbers ^ICMJE

AF219-004

Has Data Monitoring Committee

Yes

Responsible Party

Afferent Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

Afferent Pharmaceuticals, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Afferent Pharmaceuticals, Inc.

Verification Date

March 2013

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

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