Trial record 2 of 5 for:    ampio

A Efficacy and Safety Study of Two Doses of Intra-Articular Injection of Ampion™ in Adults With Pain Due to Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ampio Pharmaceuticals. Inc.
ClinicalTrials.gov Identifier:
NCT01839331
First received: April 22, 2013
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: Low Dose Ampion
Drug: High Dose Ampion
Drug: Placebo Low Dose 4 mL
Drug: Placebo 10 mL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of Intra-Articular Injection of Ampion™ in Adults With Pain Due to Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by Ampio Pharmaceuticals. Inc.:

Primary Outcome Measures:
  • Improvement in knee pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in stiffness and function, defined by the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (MERACT-OARSI) Criteria [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 329
Study Start Date: March 2013
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose Ampion
4 mL Ampion
Drug: Low Dose Ampion
4 mL Ampion
Placebo Comparator: Placebo
4 mL placebo
Drug: Placebo Low Dose 4 mL
4 mL Placebo
Experimental: High Dose Ampion
10 mL Ampion
Drug: High Dose Ampion
10 mL Ampion 10mL
Placebo Comparator: 10 mL Placebo
10 ml Placebo
Drug: Placebo 10 mL
Placebo 10 mL

Detailed Description:

A Randomized, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of two Doses of Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.

The primary trial objective is to evaluate the greater efficacy of 10 mL Ampion™ versus 10 mL placebo than 4 mL Ampion™ versus 4 mL placebo intra-articular (IA) injection in improving knee pain, when applied to patients suffering from OA of the knee.

The secondary trial objective include: the evaluation of the safety of an intra-articular injection of Ampion™ when applied to patients suffering from OA of the knee, evaluation of the efficacy of intra-articular injection of Ampion™ and placebo on stiffness and function when applied to patients suffering from OA of the knee and evaluation of responder status defined by the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) Criteria.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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.)

Exclusion Criteria:

  • 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 human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion)
  • 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:

    1. No IA injected pain medications in the study knee during the study
    2. 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
    3. No topical treatment on osteoarthritis index knee during the study
    4. No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed)
    5. No systemic treatments that may interfere with safety or efficacy assessments during the study
    6. No immunosuppressants
    7. No use of corticosteroids > 10 mg prednisolone equivalent per day (if ≤ 10 mg prednisolone, the dose must be stable)
  • Any human albumin treatment in the 3 months before randomization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839331

Sponsors and Collaborators
Ampio Pharmaceuticals. Inc.
Investigators
Study Director: Vaughan Clift, MD Ampio Pharmaceuticals. Inc.
  More Information

No publications provided by Ampio Pharmaceuticals. Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ampio Pharmaceuticals. Inc.
ClinicalTrials.gov Identifier: NCT01839331     History of Changes
Other Study ID Numbers: AP-003-A
Study First Received: April 22, 2013
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ampio Pharmaceuticals. Inc.:
osteoarthritis
osteoarthrisis of the knee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 11, 2014