Delivra-Celecoxib 8% Cream and Osteoarthritis

Osteoarthritis, Knee Clinical Trial

— Del-Cel  

Official title:

A Multicenter Observational Study on the Use of Delivra-Celecoxib 8% Cream on Pain Experienced by Patients With Osteoarthritis of the Knees

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03882749
• Other study ID #: CEL-OA-0001
• Status: Recruiting
• Start date: July 23, 2018
• Est. completion date: October 23, 2019

Study information

• Verified date: March 2019
• Source: Delivra, Inc.
• Contact: Heather Dwyer, MSc
• Phone: 9055615014
• Email: hdwyer[@]delivrainc.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: October 23, 2019
• Est. primary completion date: July 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
Canada	Dr. Andrew Chow - Rheumatologist	Mississauga	Ontario
Canada	Dr. Angela Montgomery - Rheumatologist	Mississauga	Ontario
Canada	Dr. Brandusa Florica - Rheumatologist	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Delivra, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	WOMAC	Subjects will describe pain and functionality status using a validated likert assessment .	over 12 weeks
Secondary	Adverse event reporting	Subjects will report any adverse events experienced during the study	over 12 weeks