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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ampio Pharmaceuticals. Inc.
ClinicalTrials.gov Identifier:
NCT02024529
First received: December 26, 2013
Last updated: September 17, 2014
Last verified: September 2014
  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
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: September 2014
Primary Completion Date: September 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

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT02024529

Locations
United States, California
Quang Vo, MD
Anaheim, California, United States, 92801
Sponsors and Collaborators
Ampio Pharmaceuticals. Inc.
Investigators
Study Director: Vaughan Clift, MD Ampio Pharmaceuticals. Inc.
  More Information

No publications provided

Responsible Party: Ampio Pharmaceuticals. Inc.
ClinicalTrials.gov Identifier: NCT02024529     History of Changes
Other Study ID Numbers: AP-004-A
Study First Received: December 26, 2013
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Albunex
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 02, 2015