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

NCT02024529 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: AP-004-A
• Study Type: interventional
• Target: 538
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the efficacy 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 WOMAC A 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 WOMAC C 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: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 35 years to 85 years old (inclusive) who are ambulatory but suffering from moderate to moderately severe pain from osteoarthritis in the index knee as evidenced by a rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Pain Subscale at screening.
• 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, IV). Confirmatory x-ray must be taken at Screening and assessed using Kellgren Lawrence grading system.
• Moderate to moderately-severe OA pain in the index knee even with dosing of nonsteroidal anti-inflammatory drug (NSAID) in the 4 weeks prior to screening.
• No analgesia (including acetaminophen \[paracetamol\]) taken 12 hours prior to an efficacy measure; and,
• 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.

You may not qualify if:

• Previous participation in an Ampion™ study.
• 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 OA).
• Major injury to the index knee within the 12 months prior to screening.
• Severe hip OA ipsilateral to the index knee.
• Presence of tense effusions.
• 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).
• Initiation or change in any pharmacological or non-pharmacological treatment for OA during the 4 weeks prior to randomization or likely to be changed during the duration of the study.
• Use of the following medications anticipated to be required during the study:
• Intra-articular pain medications in the study knee
• 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 needed during the study
• Use of significant anticoagulant therapy, oral or injectable, during the study (aspirin and clopidogrel are allowed)
• Systemic treatments that may interfere with safety or efficacy assessments during the study such as immunosuppressants

Sponsors & Collaborators

• Ampio Pharmaceuticals. Inc.: lead

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: December 26, 2013
• First Posted: December 31, 2013
• Study Start: January 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 9, 2022
• Results First Posted: August 9, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share