Delivra-Celecoxib 8% Cream and Osteoarthritis

NCT ID: NCT03698916

Last Updated: 2019-05-03

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-23
• Study Completion Date: 2019-05-02

Brief Summary

This is an observation of the current use of a transdermal preparation of Celecoxib 8% which is being used in the treatment of patients with primary OA of the knees. Subjects will be followed for 12 weeks.

Detailed Description

This is an observation of the current use of a transdermal preparation of Celecoxib 8% which is being used in the treatment of patients with primary OA of the knees. This transdermal celecoxib preparation is currently in use in multiple rheumatology clinics in southern Ontario, Canada. Only patients that have been prescribed the celecoxib cream will be approached for screening and subsequent study participation. The study is purely observational as the protocol does not dictate treatment or dose assignment. Subjects will be followed for 12 weeks. In addition to the baseline clinic visit, they will participate in 2 telephone calls where data will be collected on outcome assessments that measure disease severity. The data collected during those visits will be compared to baseline values of the same assessments.

Conditions

Osteoarthritis, Knee

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Celecoxib cream 8%

transdermal delivery of 8% Celecoxib

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males or Females age 30 to 75.

2. Written informed consent

3. Patients with primary osteoarthritis (with radiological evidence) of the knees who have been prescribed Del-Cel.

4. On stable pain therapy with an oral or topical NSAID or acetaminophen.

5. Able to read and understand English to answer pain assessment questions independently.

6. Willing and able to fulfill the requirements of the study, including complete scheduled follow-up phone visits.

Exclusion Criteria

1. Secondary OA of the study knee

2. History of pseudo gout or inflammatory flare-ups

3. Major surgery or previous damage to the study knee at any time, or minor knee surgery to the study knee within 1 year of visit 1.

4. Requires oral or intra-muscular corticosteroids or received an intra articular corticosteroid injection into the study knee within the past 90 days of visit 1, or into any other joint within the past 30 days of visit 1, or currently applying topical corticosteroids onto the study knee.

5. Received intra-articular viscosupplementation (eg, hylan G-F 20 [Synvisc®]) in the study knee in the past 6 months of visit 1.

6. On prior stable therapy (ie, more than 3 days per week for the previous month) with an opioid analgesic prior to the screening visit will be excluded.

7. Previously withdrawn from this study

8. History of fibromyalgia

9. Other painful or disabling conditions affecting the knee or leg, or disabling condition of the hands (used to apply the study drug)

10. Skin disorder with current involvement on the hands (used to apply the study drug) or the knee(s) (application site)

11. Referred to an orthopedic surgeon for consideration of, or been advised to have, knee replacement or knee reconstruction surgery

12. Radiologic evidence of OA of the knee advanced to the point that all cartilage has been eroded (ie, bone on bone)

13. Recently started using a cane within the past 30 days prior to visit 1.

14. History of chronic headaches, or other condition, that may require more than occasional use of rescue medication, e.g.: acetaminophen.

Subjects that do not meet all the enrollment criteria may not be enrolled. Any violations of these criteria must be reported in accordance with IRB Policies and Procedures.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Delivra, Inc.

INDUSTRY

Sponsor Role: collaborator

Credit Valley Rheumatology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Chow, MD

Role: PRINCIPAL_INVESTIGATOR

Credit Valley Rheumatology

Locations

Dr. Angela Montgomery - Rheumatologist

Mississauga, Ontario, Canada

Dr. Brandusa Florica - Rheumatologist

Mississauga, Ontario, Canada

Credit Valley Rheumatology

Mississauga, Ontario, Canada

Countries

Canada

Other Identifiers

CEL-OA-0001

Identifier Type: -

Identifier Source: org_study_id