A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis

NCT02242435 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: AP-008
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy of three intra-articular injections, given 2 weeks apart, of Ampion™ in Adults with pain due to osteoarthritis of the knee.

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis; osteoarthritis of the knee

Outcome Measures

Primary Outcomes (1)

• Change in Knee Pain

  Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.

  Scored at Baseline and 20 Weeks

Secondary Outcomes (1)

• Change in Knee Function

  Scored at Baseline and 20 Weeks

Study Arms (2)

Ampion 4ml dose

EXPERIMENTAL

4 mL intra-articular injection of Ampion

Biological: 4 mL injection of Ampion

Placebo Solution

PLACEBO COMPARATOR

4 mL placebo intra-articular injection

Drug: 4 mL Injection of Placebo

Interventions

4 mL injection of Ampion BIOLOGICAL

4 mL injection of Ampion

Ampion 4ml dose

4 mL Injection of Placebo DRUG

Also known as: Saline

Placebo Solution

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent to participate in the study.
• Willing and able to comply with all study requirements and instructions of the site study staff.
• Male or female, 40 years to 85 years old (inclusive).
• Must be ambulatory.
• Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the WOMAC® Index 3.1 5-point Likert Pain Subscale) assessed at screening and confirmed at randomization.
• Moderate to moderately-severe OA pain in the index knee (even if chronic doses of non-steroidal anti-inflammatory drug \[NSAID\], which have not changed in the 4 weeks prior to screening, have been/are being used).
• No analgesia taken 24 hours before efficacy measure.

You may not qualify if:

• As a result of medical review and screening investigation, the Principal Investigator considers the subject unfit for the study.
• Previous Ampion™ injection in the index knee.
• Known clinically significant liver abnormality (e.g., cirrhosis, transplant, etc).
• A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).
• Presence of tense effusions in the index knee.
• Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the index knee, as assessed locally by the Principal Investigator.
• Isolated patella femoral syndrome, also known as chondromalacia, in the index knee.
• Any other disease or condition interfering with the free use and evaluation of the index knee for the duration of the trial (e.g., cancer, congenital defects, spine OA).
• Major injury to the index knee within the 12 months prior to screening.
• Severe hip OA ipsilateral to the index knee.
• Any pain that could interfere with the assessment of index knee pain (e.g., pain in any other part of the lower extremities, pain radiating to the knee).
• Any pharmacological or non-pharmacological treatment targeting OA started or changed during the 4 weeks prior to treatment or likely to be changed during the duration of the study.
• IA injected pain medications in the study knee during the study;
• Analgesics containing opioids. NSAIDs may be continued at levels preceding the study and acetaminophen is available as a rescue medication during the study from the provided supply;
• Topical treatment on osteoarthritis index knee during the study;

Sponsors & Collaborators

• Ampio Pharmaceuticals. Inc.: lead

Study Sites (1)

Ampio Pharmaceuticals, Inc.

Englewood, Colorado, 80112, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Howard Levy / Chief Medical Officer
• Organization: Ampio Pharmaceuticals

clinicaltrials@ampiopharma.com

7204376500

Study Officials

• Howard Levy, M.D.

  Ampio Pharmaceuticals. Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 17, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 15, 2022
• Results First Posted: August 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)