Delivra-Celecoxib 8% Cream and Osteoarthritis

NCT03698916 | Terminated

• 1 other identifier: CEL-OA-0001
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (5)

• 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.

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

• 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.

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

• 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.

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

• 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"

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

• 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"

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

Interventions

Celecoxib cream 8% DRUG

transdermal delivery of 8% Celecoxib

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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) .

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Credit Valley Rheumatology: lead
• Delivra, Inc.: collaborator

Study Sites (3)

Dr. Angela Montgomery - Rheumatologist

Mississauga, Ontario, L5A 3V8, Canada

Location

Dr. Brandusa Florica - Rheumatologist

Mississauga, Ontario, L5A 3V8, Canada

Location

Credit Valley Rheumatology

Mississauga, Ontario, L5M 2V8, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Andrew Chow, MD

  Credit Valley Rheumatology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 9, 2018
• Study Start: July 23, 2018
• Primary Completion: May 2, 2019
• Study Completion: May 2, 2019
• Last Updated: May 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)