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AP-004-A Randomized, Controlled Study to Evaluate Efficacy and Safety of Intra-articular Ampion for Osteoarthritis Pain in Knee

This study has been completed.
Information provided by (Responsible Party):
Ampio Pharmaceuticals. Inc. Identifier:
First received: December 26, 2013
Last updated: July 27, 2016
Last verified: February 2016
This is a randomized, placebo-controlled, double-blind study in which 500 patients with osteoarthritis (OA) knee pain will be randomized to Ampion or placebo and followed for 20 weeks. The clinical effects of treatment on OA pain will be evaluated during clinic visits at 6, 12, and 20 weeks using WOMAC® osteoarthritis Index and the Patient's Global Assessment of disease severity (PGA). Safety will be assessed by recording adverse events, concomitant medications, physical examination, vital signs and clinical laboratory tests.

Condition Intervention Phase
Osteoarthritis of the Knee
Biological: Ampion
Phase 3

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
Official Title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of a Single Intra-articular Injection of AmpionTM (<5 Kilodalton Ultrafiltrate of 5% Human Serum Albumin) in Adults With Pain Due to Osteoarthritis (OA) of the Knee

Resource links provided by NLM:

Further study details as provided by Ampio Pharmaceuticals. Inc.:

Primary Outcome Measures:
  • Improvement on WOMAC A Pain SubScore [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 538
Study Start Date: December 2013
Study Completion Date: August 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ampion < 5 kDa ultrafiltrate of 5% HSA
4 mL Intra-articular injection of Ampion
Biological: Ampion
kDa ultrafiltrate of 5% human serum albumin
Placebo Comparator: Placebo solution
4 mL placebo intra-articular injection
Biological: Ampion
kDa ultrafiltrate of 5% human serum albumin


Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis and radiological evidence of symptomatic osteoarthritis of the knee
  • Moderate to severe pain

Exclusion Criteria:

  • Other conditions in the knee, e.g., crystal arthropathies, septic necrosis, joint replacement, major injury within 12 months prior to screening, tense effusions
  • Requires ongoing treatment with intra-articular pain medications or systemic corticosteroids
  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 identifier: NCT02024529

United States, Colorado
Vaughan Clift
Englewood, Colorado, United States, 80112
Sponsors and Collaborators
Ampio Pharmaceuticals. Inc.
Study Director: Vaughan Clift, MD Ampio Pharmaceuticals. Inc.
  More Information

Responsible Party: Ampio Pharmaceuticals. Inc. Identifier: NCT02024529     History of Changes
Other Study ID Numbers: AP-004-A 
Study First Received: December 26, 2013
Last Updated: July 27, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on October 21, 2016