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

NCT02873273 | Completed Phase 1 DMC

• 1 other identifier: 2015-523
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment emergent adverse events

  Through 24 weeks

• 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 Outcomes (10)

• Change from baseline in weekly mean of the pain intensity score

  Weekly through 24 weeks

• Time of onset of pain relief

  Weekly through 24 weeks

• Change from baseline in KOOS-JR score (stiffness)

  Over 1, 2, 4, 8, 12, 24 weeks post treatment

• Change from baseline in KOOS-JR score (pain)

  Over 1, 2, 4, 8, 12, 24 weeks post treatment

• Change from baseline in KOOS-JR score (function)

  Over 1, 2, 4, 8, 12, 24 weeks post treatment

Study Arms (1)

Dexamethasone delivery system

EXPERIMENTAL

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

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

Dexamethasone delivery system

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mark Figgie: lead
• Hospital for Special Surgery, New York: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Mark Figgie, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of the Surgical Arthritis Service

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 19, 2016
• Study Start: October 14, 2016
• Primary Completion: September 21, 2017
• Study Completion: September 21, 2017
• Last Updated: October 1, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)