Evaluation of Treatment Satisfaction, Effectiveness and Tolerability in Subjects treated with Low-dose Diclofenac Epolamine Soft Capsules for Acute, Mild or Moderate Musculoskeletal Pain - DHEP soft capsules in musculoskeletal pain

IBSA INSTITUT BIOCHIMIQUE SA0 sites200 target enrollmentJanuary 22, 2021

Overview

No summary available.

Registry

who.int

Start Date

January 22, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Patient is \= or \>18 years\-old;
•2\.Acute mild or moderate musculoskeletal pain such as back pain, neck pain, shoulder pain, tendon or ligament pain, myalgia) started \= 72 hours prior to inclusion in the trial. Pain can be either traumatic (e.g. due to an injury) or, postural/mechanical pain (e.g. due to postural strain, changes in posture or poor body mechanics, repetitive movements, prolonged immobilization);
•3\.Mild or moderate acute musculoskeletal pain to be defined at baseline as greater or equal to 20 mm and greater or equal to 60 mm on a 0\-100 mm on a Visual Analogue Scale. The VAS\-pain baseline assessment should be taken ensuring that no prior forbidden treatments are taken;
•4\.Informed consent obtained;
•5\.Female of childbearing potential (i.e., not permanently sterilised \- post hysterectomy or tubal ligation status – or not postmenopausal) must be using an appropriate method of contraception according to the definition of Note 3 of ICH M3 Guideline during \>\= 30 days before inclusion and for the whole duration of the study and they must have a negative pregnancy test at Visit 1\.
•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 100
•F.1\.3 Elderly (\>\=65 years) yes

•1\.Musculoskeletal pain of neuropathic or post\-surgical origin;
•2\.Musculoskeletal pain due to a chronic disease requiring treatment with NSAIDS for more than 3 days, according to the Investigator’s judgment;
•3\.Pain associated with chills or fever, or dysmenorrhea or endometriosis;
•4\.Current treatment with any muscle relaxant or any drugs having muscle relaxant properties either systemic or topical;
•5\.Known or suspected hypersensitivity, or intolerance to diclofenac and/or any other ingredient in the tested formulation;
•6\.Prior use of OTC or prescription NSAIDs within 36 hours of VAS\-pain baseline assessment with the following exceptions:
•\-subjects with prior use of long\-acting NSAIDs such as piroxicam within 72 hours before study entry or prior use of narcotic analgesics within 7 days of study entry or prior use of systemic anti\-inflammatory steroidal drugs within 30 days of study entry are excluded;
•\-subjects with prior use of paracetamol \< or \= 1000 mg, ibuprofen \< or \= 400 mg, aspirin \< or \= 600 mg are not excluded if last dose is taken \> 6 hours before the VAS assessment;
•7\.Active or suspected gastric or intestinal ulcer, bleeding or perforation and/or history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy;
•8\.History of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding);