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Completed

NCT Number: NCT01133613

Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee

The objective of the study is to determine the safety and tolerability of two different formulations of BMP-7 for the treatment of osteoarthritis of the knee.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Florida Medical Research Institute, Gainesville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ambulatory with a diagnosis of OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days.
  • >40 years
  • Radiographic evidence of at least one osteophyte in either knee at screening

Exclusion criteria

  • Concurrent medical or arthritis condition that could interfere with evaluation of index knee joint (including fibromyalgia)
  • Unwilling to abstain from NSAIDs and/or other analgesic medications for 48 hrs prior to assessments. Subjects can remain on acetaminophen up to 3.0 g daily.
  • Received arthroscopic or open surgery to the index knee within 6 months of screening
  • History of joint replacement surgery (index knee).
  • Corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening
  • Long acting hyaluronic acid injection of the index knee within 6 months of screening
  • History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, and arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia.
  • History of malignancy with the exception of resected basal cell, squamous cell of the skin, resected cervical atypia or carcinoma in situ.
  • Female subject with reproductive capability.

Treatment and study plan

Bone morphogenetic protein 7

Drug

Single intraarticular injection of BMP-7 or placebo on Day 1

Primary outcomes

  1. Safety (physical examination, vital signs, clinical laboratory measurements, adverse events)

    Time frame: Baseline, Day 2, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24

Secondary outcomes

  1. WOMAC pain and function

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 24

  2. Patient and physician global VAS

    Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24

  3. Quality of life measurement (SF-36) and pain medication use

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 24

Sponsors and collaborators

Lead sponsor

Stryker Biotech

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 31, 2010
Registry last updated
Feb 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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