A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee

NCT02556710 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: AP-003-B
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy and safety of an intra-articular injection 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 12 weeks

Secondary Outcomes (1)

• Change in Knee Function

  Scored at Baseline and 12 Weeks

Study Arms (2)

AMPION™ 4 mL dose

EXPERIMENTAL

4 mL injection of Ampion

Biological: 4 mL injection of AMPION™

Placebo 4 mL dose

PLACEBO COMPARATOR

4 mL Injection of Placebo

Drug: 4 mL injection of Placebo

Interventions

4 mL injection of AMPION™ BIOLOGICAL

4 mL Injection of Ampion

AMPION™ 4 mL dose

4 mL injection of Placebo DRUG

4 mL Injection of Placebo

Also known as: Saline

Placebo 4 mL dose

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;
• Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of OA and supported by radiological evidence (Kellgren Lawrence Grade II, III, or IV) read by a central reader;
• WOMAC 5-point Likert pain subscale \<1.5 in the contralateral knee;
• 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);
• Moderate to moderately-severe OA pain in the index knee (even if chronic doses of nonsteroidal anti-inflammatory drug (NSAID), which have not changed in the 4 weeks prior to screening, have been/are being used);
• Ability to discontinue NSAID use at Screening visit and/or 72 hours prior to the Baseline visit and for the duration of the clinical study (low dose Aspirin is allowed during the study);
• No analgesia (including acetaminophen \[paracetamol\]) taken 24 hours prior to an efficacy measure;
• No known clinically significant liver abnormality (e.g. cirrhosis, transplant, etc.).

You may not qualify if:

• As a result of medical review and screening investigation, the Principal Investigator considers the patient unfit for the study
• A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate)
• Presence of tense effusions
• Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the affected knee, as assessed locally by the Principal Investigator
• Isolated patella femoral syndrome, also known as chondromalacia
• 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 osteoarthritis)
• Major injury to the index knee within the 12 months prior to screening
• Severe hip osteoarthritis 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 randomization or likely to be changed during the duration of the study
• Pregnancy or planning to become pregnant during the study.
• Use of the following medications:
• No IA injected pain medications in the study knee during the study
• No analgesics containing opioids.
• NSAIDs are not permitted during the study; acetaminophen is available as a rescue medication during the study from the provided supply.

Sponsors & Collaborators

• Ampio Pharmaceuticals. Inc.: lead

Study Sites (1)

Ampio Pharmaceuticals

Englewood, Colorado, 80112, United States

Location

Related Publications (1)

• Cole B, McGrath B, Salottolo K, Bar-Or D. LMWF-5A for the Treatment of Severe Osteoarthritis of the Knee: Integrated Analysis of Safety and Efficacy. Orthopedics. 2018 Jan 1;41(1):e77-e83. doi: 10.3928/01477447-20171114-05. Epub 2017 Nov 21.

  PMID: 29156068 RESULT

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, MD

  Ampio Pharmaceuticals. Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• 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 18, 2015
• First Posted: September 22, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 9, 2022
• Results First Posted: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)