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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02024529
First Posted: December 31, 2013
Last Update Posted: July 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ampio Pharmaceuticals. Inc.
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024529


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

Responsible Party: Ampio Pharmaceuticals. Inc.
ClinicalTrials.gov Identifier: NCT02024529     History of Changes
Other Study ID Numbers: AP-004-A
First Submitted: December 26, 2013
First Posted: December 31, 2013
Last Update Posted: July 28, 2016
Last Verified: February 2016

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