Evaluation of Treatment Satisfaction, Effectiveness and Tolerability in Subjects treated with Low-dose Diclofenac Epolamine Soft Capsules for Acute, Mild or Moderate Musculoskeletal Pai

Phase 1

• Conditions: Patients with acute, mild or moderate musculoskeletal pain; MedDRA version: 20.0Level: PTClassification code 10028391Term: Musculoskeletal painSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2018-004886-15-IT
• Lead Sponsor: IBSA INSTITUT BIOCHIMIQUE SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-22
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

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);
9.Unexplained blood-forming disorders;
10.Established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease;
11.Severe hepatic, renal or cardiac failure;
12.Bronchospasm, asthma, urticaria, or acute rhinitis following prior aspirin or NSAIDs intake;
13.Any clinical condition that, in the opinion of the Investigator, may interfere with the study drug;
14.Subjects participated in any other protocol involving administration of an investigational agent within 3 months before Visit 1;
15.Subjects pregnant or breast feeding;
16.Unable, in the opinion of the Investigator, to comply with the study procedures.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified