Delivra-Celecoxib 8% Cream and Osteoarthritis

NCT03882749 | Unknown

• 1 other identifier: CEL-OA-0001
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

The observation of the clinical use of the Delivra Celecoxib cream (8%) in the treatment of osteoarthritis of the knee. Observations will be made over 12 weeks of treatment. Evaluations include: pain, functionality and patients global assessment of disease. Patients will self administer treatment as prescribed.

Conditions

Osteoarthritis, Knee

Keywords

Pain, WOMAC

Outcome Measures

Primary Outcomes (2)

• 11-Point Numerical Rating Scale Pain Index

  Subjects will rate he pain that they experience from 0-no pain to 10-worst pain inmmaginable

  over 12 weeks

• WOMAC

  Subjects will describe pain and functionality status using a validated likert assessment .

  over 12 weeks

Secondary Outcomes (1)

• Adverse event reporting

  over 12 weeks

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study population is all patients prescribed Del-Cel for the treatment of Osteoarthritis of the knees. The treating rheumatologist/ attending clinician will determine the appropriate course of treatment for patients as per routine clinical practice. Only patients prescribed Del-Cel will be approached for informed consent and voluntary participation in this observational study.

You may qualify if:

• Written informed consent
• Patients with primary osteoarthritis (with radiological evidence) of the knees who have been prescribed Del-Cel.
• On stable pain therapy with an oral or topical NSAID or acetaminophen.
• Able to read and understand English to answer pain assessment questions independently.
• Willing and able to fulfill the requirements of the study, including complete scheduled follow-up phone visits.

You may not qualify if:

• Inability to adequately read and understand English as required to complete study assessments and comply with the protocol.
• Current recreational or medicinal use of cannabis within 4 weeks of study initiation.
• Participants with a lifetime history of cannabis use disorder or other substance use disorders (except tobacco use disorder) will be excluded.
• Participants with a lifetime history of daily cannabis use will be excluded.
• Dose changes of concomitant medication will not be permitted during the study period.
• Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months), or women who are planning on becoming pregnant.
• Diagnosis of any of the following mental disorders as defined by the DSM-5: a lifetime history of schizophrenia or any other psychosis, organic medical disorders, bipolar disorder. Entry of patients with obsessive compulsive disorder or post- traumatic stress disorder will be permitted if the anxiety disorder is judged to be the predominant disorder, in order to increase accrual of a clinically relevant sample.
• Major depression will be allowed if not severe (Montgomery Åsberg Depression Rating Scale-MADRS27≥ 25). Patients with significant suicidal ideation (MADRS item 10 score \> 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
• Participants with a family history of schizophrenia spectrum or bipolar disorder will be excluded.
• Participants who have a history of adverse reactions to cannabis will be excluded.
• Known allergy to any of the ingredients in the Delivra base.
• Use of Rimonabant (SR141716) within three weeks of enrollment and/or planned use for the duration of the study participation\[27\].
• Use of 5-HT1A receptor antagonists (SSRI inhibitors) within three weeks of enrollment and/or planned use for the duration of the study participation, e.g.: Pindolol, Lecozotan, Brexpiprazole, etc.

Sponsors & Collaborators

• Delivra, Inc.: lead

Study Sites (3)

Dr. Angela Montgomery - Rheumatologist

Mississauga, Ontario, L5A 3V8, Canada

RECRUITING

Dr. Brandusa Florica - Rheumatologist

Mississauga, Ontario, L5A 3V8, Canada

RECRUITING

Dr. Andrew Chow - Rheumatologist

Mississauga, Ontario, L5M 2V8, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Heather Dwyer, MSc

CONTACT

9055615014; hdwyer@delivrainc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 20, 2019
• Study Start: July 23, 2018
• Primary Completion: July 23, 2019
• Study Completion: October 23, 2019
• Last Updated: March 20, 2019

Record last verified: 2019-03

Locations

CA (3)