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

Osteoarthritis, Knee Clinical Trial

Official title:

A Pilot Study of a Dexamethasone Implant System in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02873273
• Other study ID #: 2015-523
• Status: Completed
• Phase: Phase 1
• Start date: October 14, 2016
• Est. completion date: September 21, 2017

Study information

• Verified date: September 2018
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 21, 2017
• Est. primary completion date: September 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 99 Years

Eligibility

Inclusion Criteria

• Male or female = 40 years of age at time of consent

• Diagnosis of unilateral or bilateral knee osteoarthritis for at least 6 months prior to screening with confirmation of osteoarthritis according to the American College of Rheumatology Criteria for Classification of Idiopathic Osteoarthritis of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to screening or during the screening period

• Kellgren - Lawrence grade =2 on weight bearing anteroposterior femorotibial radiograph performed within 6 months prior to or during screening period

• Mean score of = 5 and = 10 on the 24 hour average pain score (0 - 10 Numeric Rating System) during the screening period

• Body mass index (BMI) = 40 kg/m2

• Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions

• Willingness to stop all pain medications except acetaminophen and paracetamol 14 days prior to implantation

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Dexamethasone
Sustained delivery system containing 5.0 mg of dexamethasone programmed to release an estimated 10 µg per day

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Mark Figgie	Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events		Through 24 weeks
Primary	Change from baseline in weekly mean of the pain intensity score	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	Weeks 12, 24
Secondary	Change from baseline in weekly mean of the pain intensity score	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	Weekly through 24 weeks
Secondary	Time of onset of pain relief		Weekly through 24 weeks
Secondary	Change from baseline in KOOS-JR score (stiffness)	Using a response scale of none, mild, moderate, severe, and extreme	Over 1, 2, 4, 8, 12, 24 weeks post treatment
Secondary	Change from baseline in KOOS-JR score (pain)	Using a response scale of none, mild, moderate, severe, and extreme	Over 1, 2, 4, 8, 12, 24 weeks post treatment
Secondary	Change from baseline in KOOS-JR score (function)	Using a response scale of none, mild, moderate, severe, and extreme	Over 1, 2, 4, 8, 12, 24 weeks post treatment
Secondary	Change in patient's global impression of scores assessed via office visits	Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable)	Weeks 4, 12, 24
Secondary	Change in clinical observer's global impression of scores assessed via office visits	Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable)	Weeks 4, 12, 24
Secondary	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
Secondary	Average weekly consumption of rescue medications		Through 24 weeks
Secondary	Average total consumption of rescue medications		Through 24 weeks