celecoxib after collagenase injection in Dupuytren's disease

A randomised, double-blind, placebo-controlled study of celecoxib after collagenase injection for adults with Dupuytren’s disease at high risk of recurrence

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000717-31-BE

Enrollment

Registered

2015-05-12

Start date

2015-06-09

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytren's disease MedDRA version: 18.0 Level: PT Classification code 10051062 Term: Wrist surgery System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Celebrex Product Name: Celebrex Product Code: LI900005 Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Dupuytren’s patients with risk score D of Abe1 > 4. Dupuytren’s diathesis, and thus risk for recurrence or extension after surgery, is evaluated according to the D-score (diathesis) formulated by Abe1: (a) bilateral hand involvement ( with = 1, without = 0), (b) little finger surgery ( with = 1, without = 0), (c) early onset before the age of 50years (1-0), (d) plantar fibrosis (2-0), (e) knuckle pads (2-0) and (f) radial side involvement (2-0). D = a + b + c + d + e + f. If the D-score is higher than 4, there is a high risk of recurrence and extension. Patients must be scheduled to undergo treatment with collagenase injections. Age > 18 years at the time of the informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Exclusion criteria or contra-indications as per Summary of Product Characteristics (appendix 9). ? Current administration of another NSAID or anticoagulant. ? History or evidence of any other clinically significant disorder, malignancies, condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. ? Patient likely to not be available to complete all protocol-required study visits or procedures, including follow-up visits, and/or to comply with all required study procedures. ? Known exclusion criteria to celecoxib (see appendix 9 for patient leaflet)

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to evaluate the ability of celecoxib to improve the treatment result (improved finger extension) of collagenase in Dupuytren’s patients at high risk for disease recurrence, when administered after the collagenase injection.;Secondary Objective: A. Tubiana grading will also be performed in order to obtain the sum of the total passive extension deficits (TPED) of a given hand (grade I: 0°- 45° passive extension deficit, grade II: 45°-90°, grade III: 90°-135°, grade IV: = 135°). This will allow defining if celecoxib is more efficient in, for instance, the less affected hands. Grading occurs at the same occasions as TPED. C. The DASH questionnaire will be filled in by the patients, preoperatively, and after 1 and 2 years. See addendum. It consists of 30 questions about the activities of daily living. The scores are added and transformed into a 100-point scale. The higher the result, the worse the condition of the patient. D. The 'visual analogue satisfaction and pain score' (VAS) will be made up by the patient at every visit.;Primary end point(s): A. The Total Passive Extension Deficit (TPED) of the MCP, PIP and DIP joints of each affected ray will be measured with an electronic goniometer, by two independent orthopaedic surgeons. The study will focus on individual rays, rather than on patients, especially for computation of the data. This TPED will be measured before surgery (clinical data sheet) and 4 and 12 weeks, 6 months, 1 and 2 years after surgery. Clinical pictures will be made preoperatively and at every follow-up evaluation (palmar view and ulnar view, as a back-up).;Timepoint(s) of evaluation of this end point: Dec 2018	—

Measure

Time frame

Main Objective: The purpose of this study is to evaluate the ability of celecoxib to improve the treatment result (improved finger extension) of collagenase in Dupuytren’s patients at high risk for disease recurrence, when administered after the collagenase injection.;Secondary Objective: A. Tubiana grading will also be performed in order to obtain the sum of the total passive extension deficits (TPED) of a given hand (grade I: 0°- 45° passive extension deficit, grade II: 45°-90°, grade III: 90°-135°, grade IV: = 135°). This will allow defining if celecoxib is more efficient in, for instance, the less affected hands. Grading occurs at the same occasions as TPED. C. The DASH questionnaire will be filled in by the patients, preoperatively, and after 1 and 2 years. See addendum. It consists of 30 questions about the activities of daily living. The scores are added and transformed into a 100-point scale. The higher the result, the worse the condition of the patient. D. The 'visual analogue satisfaction and pain score' (VAS) will be made up by the patient at every visit.;Primary end point(s): A. The Total Passive Extension Deficit (TPED) of the MCP, PIP and DIP joints of each affected ray will be measured with an electronic goniometer, by two independent orthopaedic surgeons. The study will focus on individual rays, rather than on patients, especially for computation of the data. This TPED will be measured before surgery (clinical data sheet) and 4 and 12 weeks, 6 months, 1 and 2 years after surgery. Clinical pictures will be made preoperatively and at every follow-up evaluation (palmar view and ulnar view, as a back-up).;Timepoint(s) of evaluation of this end point: Dec 2018

—

Secondary

Measure	Time frame
Secondary end point(s): B. Tubiana grading will also be performed in order to obtain the sum of the total passive extension deficits (TPED) of a given hand (grade I: 0°- 45° passive extension deficit, grade II: 45°-90°, grade III: 90°-135°, grade IV: = 135°). This will allow defining if celecoxib is more efficient in, for instance, the less affected hands. Grading occurs at the same occasions as TPED. C. The DASH questionnaire will be filled in by the patients, preoperatively, and after 1 and 2 years. See addendum. It consists of 30 questions about the activities of daily living. The scores are added and transformed into a 100-point scale. The higher the result, the worse the condition of the patient. D. The 'visual analogue satisfaction and pain score' (VAS) will be made up by the patient at every visit.;Timepoint(s) of evaluation of this end point: Dec 2018	—

Measure

Time frame

Secondary end point(s): B. Tubiana grading will also be performed in order to obtain the sum of the total passive extension deficits (TPED) of a given hand (grade I: 0°- 45° passive extension deficit, grade II: 45°-90°, grade III: 90°-135°, grade IV: = 135°). This will allow defining if celecoxib is more efficient in, for instance, the less affected hands. Grading occurs at the same occasions as TPED. C. The DASH questionnaire will be filled in by the patients, preoperatively, and after 1 and 2 years. See addendum. It consists of 30 questions about the activities of daily living. The scores are added and transformed into a 100-point scale. The higher the result, the worse the condition of the patient. D. The 'visual analogue satisfaction and pain score' (VAS) will be made up by the patient at every visit.;Timepoint(s) of evaluation of this end point: Dec 2018

—

Countries

Belgium

Contacts

Public ContactClinial Trial Information Desk

Orthosearch

orthopedic.research@uz.kuleuven.be003216338817

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026