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Osteoarthritis, KneeNCT03698916

Delivra-Celecoxib 8% Cream and Osteoarthritis

An observational study of Osteoarthritis, Knee, run by Credit Valley Rheumatology at 3 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Celecoxib cream 8%
How many people
6 participants
Where
3 sitesCanada
Study dates
23 Jul 2018to 2 May 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
  • Adult, Older adult

Study population: Primary OA patients of the three rheumatology clinics included in this study protocol that have been prescribed the Delivra Celecoxib Cream 8% (Del-Cel) .

Who may be able to join

  • Males or Females age 30 to 75.
  • 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

  • Secondary OA of the study knee
  • History of pseudo gout or inflammatory flare-ups
  • 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.
  • 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.
  • Received intra-articular viscosupplementation (eg, hylan G-F 20 [Synvisc®]) in the study knee in the past 6 months of visit 1.
  • 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.
Show all 15Show fewer
  • Previously withdrawn from this study
  • History of fibromyalgia
  • Other painful or disabling conditions affecting the knee or leg, or disabling condition of the hands (used to apply the study drug)
  • Skin disorder with current involvement on the hands (used to apply the study drug) or the knee(s) (application site)
  • Referred to an orthopedic surgeon for consideration of, or been advised to have, knee replacement or knee reconstruction surgery
  • Radiologic evidence of OA of the knee advanced to the point that all cartilage has been eroded (ie, bone on bone)
  • Recently started using a cane within the past 30 days prior to visit 1.
  • 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.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Dr. Angela Montgomery - Rheumatologist

    Mississauga, Ontario, L5A 3V8

  • Dr. Brandusa Florica - Rheumatologist

    Mississauga, Ontario, L5A 3V8

  • Credit Valley Rheumatology

    Mississauga, Ontario, L5M 2V8

Other trials in Canada

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.

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.

Read the 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.

Being tested
Celecoxib cream 8%
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Celecoxib cream 8%Drug

    transdermal delivery of 8% Celecoxib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Can study personnel enrol at least 70% of all eligible patients.

    The screening log will be reviewed to determine how many eligible participants consented to study participation. The evaluation may also include reasons for ineligibility. This objective will be met if the threshold of least 70% is met.

    Measured: This data will be collected during recruitment. Recruitment will end when the enrolment target of 45 subjects has been met.

  2. Can study personnel collect 100% of the data scheduled to be collected from at least 70% of the enrolled subjects.

    This objective will be met if 100% of study assessments (Western Ontario and McMaster University (WOMAC) Osteoarthritis index scores, Numeric Rating Score (NRS) Pain Index and Patient Global Assessment (PGA) score) is collected from ≥ 70% of the enrolled patients.

    Measured: Baseline data will be compared to data collected after 12-weeks of treatment.

  3. Calculate the Sample standard deviation of Western Ontario and McMaster University (WOMAC) Osteoarthritis index scores from this population.

    Higher WOMAC scores indicate an increase in disease severity, i.e.: increased pain and decrease functionality. The mean and standard deviation of the sample will be calculated from the observations collected for WOMAC assessment. It will be used for future sample size calculations.

    Measured: Baseline data will be compared to data collected after 12-weeks of treatment.

  4. Calculate Sample standard deviations of Patient Global Assessment (PGA) scores from this population.

    The standard deviations will be calculated from the observations collected for PGA. It will be used for future sample size calculations. Higher scores reflect greater disease severity from the patient's perspective. Scores range from 0- "No symptoms" to 10 "Worst symptoms imaginable"

    Measured: Baseline data will be compared to data collected after 12-weeks of treatment.

  5. Calculate Sample standard deviations of Numeric Rating Score (NRS) Pain Index from this population.

    The standard deviations will be calculated from the observations collected for NRS assessment. It will be used for future sample size calculations. Higher pain scores indicate grater pain experienced by the subject. Scores range from 0- "No pain" to 10 "Worst pain imaginable"

    Measured: Baseline data will be compared to data collected after 12-weeks of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2018
  2. Study start23 Jul 2018
  3. Primary completion2 May 2019
  4. Study completion2 May 2019

Why it stopped: Unable to recruit

Resources

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03698916
Sponsor's protocol ID
CEL-OA-0001
Status last verified
May 2019
First submitted
2 Oct 2018
Last updated
3 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis, Knee, run by Credit Valley Rheumatology 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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 3 May 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?

The study was stopped early (reason given: Unable to recruit). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Can study personnel enrol at least 70% of all eligible patients. (time frame: This data will be collected during recruitment. Recruitment will end when the enrolment target of 45 subjects has been met.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03698916.

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 3 May 2019.

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