Clinical study of the combination of Dexketoprofen and Paracetamol in acute musculoskeletal pain

Phase 3

Completed

• Conditions: Acute musculoskeletal pain

• Registration Number: CTRI/2009/091/000114
• Lead Sponsor: Emcure Pharmaceuticals Limited Pune

Brief Summary

This is a comparative, randomized, multicentric, clinical trial to evaluate the efficacy and tolerability of FDC of Dexketoprofen and Paracetamol in acute musculoskeletal pain. This study is presently being conducted in 100 patients from various centers in India. Patients will be randomized to receive either Fixed Dose Combination of Dexketoprofen trometamol (25 mg) and Paracetamol (500 mg) or Fixed Dose Combination of Diclofenac sodium (50 mg) and Paracetamol (500 mg). Dose will be one tablet to be taken orally, thrice daily for three consecutive days. Major outcomes measured will be Responder rate, reduction in pain intensity on VAS, Sum of analogue pain intensity differences (SAPID) on visual analogue scale (VAS), Sum of pain intensity differences (SPID) on categorical verbal scale (VS), Total pain relief score (TOTPAR) on VS, patients and physician’s global assessment and ADR.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-16
• Last Update Posted: 2012-10-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

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

1.Patients previously sensitive to dexketoprofen, to diclofenac, to paracetamol, to any other NSAID, or to any of the ingredients of the product2.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 failure8.Patients with moderate to severe renal dysfunction9.Patients with severely impaired hepatic function10.Patients with hemorrhagic diathesis and other coagulation disorders11.Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception12.Treatment with other analgesic and/or anti-inflammatory agent13.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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The responder rate, defined as the percent of patients showing at least 50% improvement on VAS.	0,1,6,12,24,48 and 72 hours

Secondary Outcome Measures

Name	Time	Method
Total pain relief score (TOTPAR) on VS.	0,1,6,12,24,48 and 72 hours
Patient?s global assessment of the efficacy of the drug	0,1,6,12,24,48 and 72 hours
Physician?s global assessment of the efficacy of the drug	0,1,6,12,24,48 and 72 hours
Sum of pain intensity differences (SPID) on categorical verbal scale (VS).	0,1,6,12,24,48 and 72 hours
Sum of analogue pain intensity differences (SAPID) on visual analogue scale (VAS)	0,1,6,12,24,48 and 72 hours

Trial Locations

Locations (7)

City Medical Center; 🇮🇳 Center,Shaniwar, India

Hardikar Hospital, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Panse Clinic, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Patil Orthopaedic Hospital; 🇮🇳 Hospital,Shaniwar, India

Pune Institute of Accident and Orthopedics, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Shri Shankarrao Chavan Government Medical College, Vajirabad, Nanded; 🇮🇳 Nanded, MAHARASHTRA, India

Suman Accident Hospital, Pune; 🇮🇳 Pune, MAHARASHTRA, India

City Medical Center

🇮🇳Center,Shaniwar, India

Dr. Paresh Patil

Principal investigator

02164225959

alaukika@dataone.in