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

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ClinicalTrials.gov Identifier: NCT02024529
Recruitment Status : Completed
First Posted : December 31, 2013
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Ampio Pharmaceuticals. Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis of the Knee Biological: Ampion Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 538 participants
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
Study Start Date : December 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Improvement on WOMAC A Pain SubScore [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
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

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.

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

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