Health Condition 1: null- Acute musculoskeletal pain
Conditions
Interventions
Intervention1: FDC of Dexketoprofen trometamol (25 mg) and Paracetamol (500 mg): Dose and duration- One tablet to be taken orally, thrice daily for three consecutive days.
Control Intervention1: FDC o
Sponsors
Emcure Pharmaceuticals Limited Pune
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients between 18-65 years of age. 2. Patients having acute musculoskeletal pain e.g. musculoskeletal injuries, myalgia, neck pain, limb pain, low back pain, joint pain, widespread musculoskeletal pain 3. Patients willing to give written informed consent and willing to comply with trial protocol. comply with trial protocol.
Exclusion criteria
Exclusion criteria: 1. Patients previously sensitive to dexketoprofen, to diclofenac, to paracetamol, to any other NSAID, or to any of the ingredients of the product 2. Patients in whom substances with a similar action (e.g. Aspirin, or other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic oedema. 3. Patients with active or suspected gastrointestinal ulcer or history of gastrointestinal ulcer or chronic dyspepsia. 4. Patients who have gastrointestinal bleeding or other active bleedings or bleeding disorders. 5. Patients with Crohn?s disease or ulcerative colitis. 6. Patients with a history/ presence of bronchial asthma. 7. Patients with severe heart failure 8. Patients with moderate to severe renal dysfunction 9. Patients with severely impaired hepatic function 10. Patients with hemorrhagic diathesis and other coagulation disorders 11. Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception 12. Treatment with other analgesic and/or anti-inflammatory agent 13. Patients who will receive some other drug during the study besides that in the protocol that could alter the bioavailability of the study drug 14. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The responder rate, defined as the percent of patients showing at least 50% improvement on VAS.Timepoint: 0,1,6,12,24,48 and 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient?s global assessment of the efficacy of the drugTimepoint: 0,1,6,12,24,48 and 72 hours;Physician?s global assessment of the efficacy of the drugTimepoint: 0,1,6,12,24,48 and 72 hours;Sum of analogue pain intensity differences (SAPID) on visual analogue scale (VAS)Timepoint: 0,1,6,12,24,48 and 72 hours;Sum of pain intensity differences (SPID) on categorical verbal scale (VS).Timepoint: 0,1,6,12,24,48 and 72 hours;Total pain relief score (TOTPAR) on VS.Timepoint: 0,1,6,12,24,48 and 72 hours | — |
Countries
India
Contacts
Public ContactDr Sudhir Surwade
Manager-Clinical Projects
Outcome results
None listed