An Efficacy and Safety Study of Two Doses of Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee

NCT01839331 | Completed Phase 2 Results DMC

• 1 other identifier: AP-003-A
• Study Type: interventional
• Target: 329
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the efficacy of two doses of 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 (3)

• Change in Knee Function

  Scored at Baseline and 12 weeks.

• Change in Knee Stiffness.

  Scored at Baseline and 12 weeks.

• Change in Patient's Global Assessment

  Scored at Baseline and 12 weeks.

Study Arms (4)

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

Ampion 10 mL Dose

EXPERIMENTAL

10 mL Injection of Ampion

Biological: 10 mL Injection of Ampion

Placebo 10 mL Dose

PLACEBO COMPARATOR

10 mL Injection of Placebo

Drug: 10 mL Injection of Placebo

Interventions

4 mL injection of Ampion BIOLOGICAL

4 mL Injection of Ampion

Ampion 4 mL Dose

10 mL Injection of Ampion BIOLOGICAL

10 mL Injection of Ampion

Ampion 10 mL Dose

4 mL Injection of Placebo DRUG

4 mL Injection of Placebo

Also known as: Saline

Placebo 4 mL Dose

10 mL Injection of Placebo DRUG

10 mL Injection of Placebo

Also known as: Saline

Placebo 10 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 osteoarthritis (OA) and supported by radiological evidence Kellgren Lawrence Grade II to IV) that is not older than 6 months prior to the date of screening
• 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
• 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)
• No analgesia (including acetaminophen \[paracetamol\]) taken 12 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 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 randomization or likely to be changed during the duration of the study
• Use of the following medications:
• No IA injected pain medications in the study knee during the study
• No 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
• No topical treatment on osteoarthritis index knee during the study
• No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed)

Sponsors & Collaborators

• Ampio Pharmaceuticals. Inc.: lead

Related Publications (1)

• Bar-Or D, Salottolo KM, Loose H, Phillips MJ, McGrath B, Wei N, Borders JL, Ervin JE, Kivitz A, Hermann M, Shlotzhauer T, Churchill M, Slappey D, Clift V. A randomized clinical trial to evaluate two doses of an intra-articular injection of LMWF-5A in adults with pain due to osteoarthritis of the knee. PLoS One. 2014 Feb 3;9(2):e87910. doi: 10.1371/journal.pone.0087910. eCollection 2014.

  PMID: 24498399 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

Limitations and Caveats

The relatively small number of subjects in each arm may account for lack of statistical significance of improvement in Knee pain of 10 mL.

Results Point of Contact

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

clinicaltrials@ampiopharma.com

720-437-6500

Study Officials

• Howard Levy, MD

  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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: April 24, 2013
• Study Start: March 29, 2013
• Primary Completion: August 19, 2013
• Study Completion: October 1, 2013
• Last Updated: June 30, 2022
• Results First Posted: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share