Osteoarthritis, KneeDel-CelNCT03882749
Delivra-Celecoxib 8% Cream and Osteoarthritis
An observational study of Osteoarthritis, Knee, run by Delivra, Inc. at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- How many people
- 45 participants
- Where
- 3 sitesCanada
- Study dates
- 23 Jul 2018to 23 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Recruiting
Dr. Angela Montgomery - Rheumatologist
Mississauga, Ontario, L5A 3V8
Quinn Thomson, (905) 848-2444, qthomson@nkshealth.ca
- Recruiting
Dr. Brandusa Florica - Rheumatologist
Mississauga, Ontario, L5A 3V8
Quinn Thomson, (905) 848-2444, qthomson@nkshealth.ca
- Recruiting
Dr. Andrew Chow - Rheumatologist
Mississauga, Ontario, L5M 2V8
Judy Hum
905-606-2210, cvrheumatology@yahoo.ca
About this study
Official title: A Multicenter Observational Study on the Use of Delivra-Celecoxib 8% Cream on Pain Experienced by Patients With Osteoarthritis of the Knees
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
- Medical subject headings
- Osteoarthritis, Knee, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
11-Point Numerical Rating Scale Pain Index
Subjects will rate he pain that they experience from 0-no pain to 10-worst pain inmmaginable
Measured: over 12 weeks
WOMAC
Subjects will describe pain and functionality status using a validated likert assessment .
Measured: over 12 weeks
Secondary outcomes (1)
Adverse event reporting
Subjects will report any adverse events experienced during the study
Measured: over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start23 Jul 2018
- Primary completion23 Jul 2019 (estimated)
- Study completion23 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Delivra, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882749
- Sponsor's protocol ID
- CEL-OA-0001
- Acronym
- Del-Cel
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2019
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Observational Study on the Use of Delivra-Celecoxib 8% Cream on Pain Experienced by Patients With Osteoarthritis of the Knees
- ClinicalTrials.gov ID
- NCT03882749
- Acronym / sponsor ID
- Del-Cel / CEL-OA-0001
- Conditions
- Osteoarthritis, Knee
- Keywords
- Pain, WOMAC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Delivra, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 23 Jul 2019 (estimated)
- Study completion
- 23 Oct 2019 (estimated)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
11-Point Numerical Rating Scale Pain Index
Time frame: over 12 weeks
Subjects will rate he pain that they experience from 0-no pain to 10-worst pain inmmaginable
WOMAC
Time frame: over 12 weeks
Subjects will describe pain and functionality status using a validated likert assessment .
1 secondary outcome
Adverse event reporting
Time frame: over 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Delivra, Inc. at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heather Dwyer, MSc (9055615014, hdwyer@delivrainc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
11-Point Numerical Rating Scale Pain Index (time frame: over 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.