Delivra-Celecoxib 8% Cream and Osteoarthritis

• ClinicalTrials.gov Identifier: NCT03698916
• Recruitment Status: Terminated
• First Posted: October 9, 2018
• Last Update Posted: May 3, 2019
• Sponsor: Credit Valley Rheumatology
• Collaborator: Delivra, Inc.
• Information provided by (Responsible Party): Credit Valley Rheumatology

Study Description

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.

Condition or disease	Intervention/treatment
Osteoarthritis, Knee	Drug: Celecoxib cream 8%

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 6 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Multicenter Observational Study on the Use of Delivra-Celecoxib 8% Cream on Pain Experienced by Patients With Osteoarthritis of the Knees.
• Actual Study Start Date: July 23, 2018
• Actual Primary Completion Date: May 2, 2019
• Actual Study Completion Date: May 2, 2019

Groups and Cohorts

Intervention Details:

• Drug: Celecoxib cream 8%
  transdermal delivery of 8% Celecoxib

Outcome Measures

Primary Outcome Measures :

1. 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 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.
2. Can study personnel collect 100% of the data scheduled to be collected from at least 70% of the enrolled subjects. [ Time Frame: Baseline data will be compared to data collected after 12-weeks of treatment. ]
   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.
3. Calculate the Sample standard deviation of Western Ontario and McMaster University (WOMAC) Osteoarthritis index scores from this population. [ Time Frame: Baseline data will be compared to data collected after 12-weeks of treatment. ]
   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.
4. Calculate Sample standard deviations of Patient Global Assessment (PGA) scores from this population. [ Time Frame: Baseline data will be compared to data collected after 12-weeks of treatment. ]
   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"
5. Calculate Sample standard deviations of Numeric Rating Score (NRS) Pain Index from this population. [ Time Frame: Baseline data will be compared to data collected after 12-weeks of treatment. ]
   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"

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

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) .

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.

Contacts and Locations

Locations

Canada, Ontario

Dr. Angela Montgomery - Rheumatologist

Mississauga, Ontario, Canada, L5A 3V8

Dr. Brandusa Florica - Rheumatologist

Mississauga, Ontario, Canada, L5A 3V8

Credit Valley Rheumatology

Mississauga, Ontario, Canada, L5M 2V8

Sponsors and Collaborators

Credit Valley Rheumatology

Delivra, Inc.

Investigators

• Principal Investigator: Andrew Chow, MD; Credit Valley Rheumatology

More Information

• Responsible Party: Credit Valley Rheumatology
• ClinicalTrials.gov Identifier: NCT03698916
• Other Study ID Numbers: CEL-OA-0001
• First Posted: October 9, 2018
• Last Update Posted: May 3, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Celecoxib; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action