Patients with acute, mild or moderate musculoskeletal pain MedDRA version: 20.0 Level: PT Classification code 10028391 Term: Musculoskeletal pain System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: FLECTORGO 12,5 mg capsule molli
Product Name: Diclofenac epolamine 12,5 mg soft capsules
Product Code: [Diclofenac epolamine 12, 5 mg soft capsules]
Pharmaceutical Form: Capsule, soft
INN
Sponsors
IBSA INSTITUT BIOCHIMIQUE SA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the overall subject’s satisfaction with 12.5 mg diclofenac soft capsules (FLECTORGO 12.5 mg) when used as needed according to the approved dose regimen and administration conditions, in patients with acute, mild or moderate musculoskeletal pain;Secondary Objective: To evaluate the analgesic effect after the first diclofenac soft capsule administration (over 0-3 hours), over 0-24 hours, 0-48 hours and 0-72 hours and the time to onset of the analgesic effect; to assess the subject’s satisfaction with efficacy in terms of time to pain relief, amount of pain relief, and duration of pain relief; to evaluate safety and tolerability of the product.;Primary end point(s): Proportion (%) of participants overall satisfied (very satisfied or satisfied) with FLECTORGO 12.5 mg 72 ± 7 hours after initiation of treatment as assessed using the Overall Satisfaction Question of the Pain Treatment Satisfaction Scale (PTSS). Responses will be rated from very satisfied (1) to very dissatisfied (5).;Timepoint(s) of evaluation of this end point: For all the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Sum of pain intensity difference (VAS SPID) (calculated as AUC) over 0-3 hours (SPID-3), over 0-24 hours (SPID-24) after time 0, over 0-48 hours (SPID-48), and over 0-72 hours (SPID-72) after time 0 or until the last VAS time point after the last intake if treatment is not taken over three days; • VAS Pain intensity difference (PID) based on subject’s self-assessment of pain intensity by means of VAS at each scheduled assessment time point after the first dose; • Time to onset of the analgesic effect as expressed by asking the subject 1 hour after each diclofenac intake the time (in minutes) he/she experienced: - a slight pain relief; - a significant pain relief; - a complete pain relief; • Proportion (%) of participants satisfied (very satisfied or satisfied) with the Efficacy - Time to Pain Relief 72 ± 7 hours after initiation of treatment with FLECTORGO as assessed using the Efficacy - Time to Pain Relief Satisfaction Question (=time it took medication to work) of the PTSS. Responses will be rated from very satisfied (1) to very dissatisfied (5); • Proportion (%) of participants satisfied (very satisfied or satisfied) with the Efficacy – Amount of Pain Relief 72 ± 7 hours after initiation of treatment with FLECTORGO as assessed using the Efficacy – Amount of Pain Relief Satisfaction Question (=the amount of pain relief provided by the medication) of the PTSS. Responses will be rated from very satisfied (1) to very dissatisfied (5); • Proportion (%) of participants satisfied (very satisfied or satisfied) with the Efficacy – Duration of Pain Relief 72 ± 7 hours after initiation of treatment with FLECTORGO as assessed using the Efficacy – Duration of Pain Relief Satisfaction Question (=the duration of pain relief provided by the medication) of the PTSS. Responses will be rated from very satisfied (1) to very dissatisfied (5).;Timepoint(s) of evaluation of this end point: For all the study period | — |
Countries
Italy
Contacts
Public ContactR&D Scientific Affairs IBSA
IBSA Institut Biochimique SA
Outcome results
None listed