Study of a Steroid Delivery System for Pain Relief Treatment in Patients With Knee Osteoarthritis

Phase 1

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Dexamethasone

• Registration Number: NCT02873273
• Lead Sponsor: Mark Figgie

Brief Summary

The purpose of this study is to determine whether a longer duration, controlled, sustained release dexamethasone delivery system would be more effective in helping patients with osteoarthritis reduce their pain, remain functional, and delay their need for knee replacement.

Detailed Description

The objectives of the study are to assess the dexamethasone delivery system for:

* Safety and tolerability

* Efficacy

Formal statistical analysis to compare treatment groups will not be performed due to the small number of participants in this pilot study. Summary statistics will be assessed using the short form of the knee injury and osteoarthritis outcome score (KOOS JR) surveys and questionnaires to assess pain intensity, pain medication consumption and wound assessment.

Study Timeline

• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Study Start: 2016-10-14
• Primary Completion: 2017-09-21
• Study Completion: 2017-09-21
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-28
• Last Update Posted: 2018-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

• Fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
• History of inflammatory arthritis including rheumatoid arthritis, juvenile inflammatory arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, reactive arthritis
• Hemophilia
• Achondroplasia
• History of infection in the index joint
• Intra-articular corticosteroid (investigational or marketed) in any joint within three months of screening
• Intra-articular hyaluronic acid (investigational or marketed) in the index knee within three months of screening
• Oral, inhaled, and intranasal corticosteroids (investigational or marketed) within one month of screening
• Prior arthroscopic or open surgery of the index knee within 12 months of screening
• Planned / anticipated surgery of the index knee during the study period
• Active or history of malignancy within the last five years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
• Insulin dependent diabetes
• History of or active Cushing's syndrome
• Skin breakdown at index knee where procedure would take place
• Women of child-bearing potential
• Case history related to motor vehicle accident or workers compensation
• Presence of hardware in the index knee (e.g. screws, plates)
• Immunocompromised patients (TB, HIV, etc.)
• Allergic reactions to acetaminophen and paracetamol

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexamethasone delivery system	Dexamethasone	-

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events	Through 24 weeks
Change from baseline in weekly mean of the pain intensity score	Weeks 12, 24	Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable) at rest, during activity, and at night

Secondary Outcome Measures

Name	Time	Method
Percent of responders (defined as patients with high improvement in pain or function) according to OMERACT-OARSI criteria	Weeks 1, 2, 4, 8, 12, 24
Average weekly consumption of rescue medications	Through 24 weeks
Change from baseline in KOOS-JR score (stiffness)	Over 1, 2, 4, 8, 12, 24 weeks post treatment	Using a response scale of none, mild, moderate, severe, and extreme
Change from baseline in KOOS-JR score (pain)	Over 1, 2, 4, 8, 12, 24 weeks post treatment	Using a response scale of none, mild, moderate, severe, and extreme
Change in patient's global impression of scores assessed via office visits	Weeks 4, 12, 24	Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable)
Average total consumption of rescue medications	Through 24 weeks
Change from baseline in weekly mean of the pain intensity score	Weekly through 24 weeks	Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable) at rest, during activity, and at night
Time of onset of pain relief	Weekly through 24 weeks
Change in clinical observer's global impression of scores assessed via office visits	Weeks 4, 12, 24	Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable)
Change from baseline in KOOS-JR score (function)	Over 1, 2, 4, 8, 12, 24 weeks post treatment	Using a response scale of none, mild, moderate, severe, and extreme

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States