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

Information source: Ampio Pharmaceuticals. Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis of the Knee

Intervention: Ampion (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Ampio Pharmaceuticals. Inc.

Official(s) and/or principal investigator(s):
Vaughan Clift, MD, Study Director, Affiliation: Ampio Pharmaceuticals. Inc.

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.

Clinical Details

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

Primary outcome: Improvement on WOMAC A Pain SubScore

Eligibility

Minimum age: 35 Years. Maximum age: 85 Years. Gender(s): Both.

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

Locations and Contacts

Quang Vo, MD, Anaheim, California 92801, United States
Additional Information

Starting date: December 2013
Last updated: September 17, 2014

Page last updated: August 23, 2015

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