A post marketing study to assess the safety and efficacy of three different pain killer combinations in patients with acute painful conditions

Phase 4

• Conditions: Health Condition 1: G891- Acute pain, not elsewhere classifiedHealth Condition 2: K089- Disorder of teeth and supporting structures, unspecifiedHealth Condition 3: M545- Low back painHealth Condition 4: G438- Other migraineHealth Condition 5: M658- Other synovitis and tenosynovitisHealth Condition 6: S934- Sprain of ankle

• Registration Number: CTRI/2023/03/050849
• Lead Sponsor: Alkem Laboratories Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients of either gender >= 18 years of age

2.Patients with acute painful conditions like low back pain, acute musculoskeletal disorders and trauma such as tendinitis, tenosynovitis, bursitis, sprains and strains, migraine, dental pain, painful dental procedures and post-surgical pain receiving either FDC of nimesulide-paracetamol or FDC of aceclofenac-paracetamol or ketorolac as per routine clinical practice

3.Patients willing to provide written informed consent

Exclusion Criteria

1.Patients with past history of hypersensitivity to study drugs

2.Patients who have used NSAIDS or any other analgesic in last 24 hours

3.Patients with history of GI bleeding

4.Patients with clinically significant uncontrolled cardiovascular disease

5.Patients with hepatic dysfunction (serum transaminases >= 3 x Upper Normal Limit) or renal dysfunction (serum creatinine >= 2.5 mg/dl) at screening

6.Pregnant and lactating mothers and women of child bearing potential who are not taking adequate contraceptive measures

7.Patients prescribed / require any other medication known to interact with the study medication.

8.Any other reason for which the investigator feels that the patient should not participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of pain as measured by numerical rating scale as compared to baseline in the three groupsTimepoint: 7 days and 14 days

Secondary Outcome Measures

Name	Time	Method
Cardiovascular adverse events (any MI, any stroke or any CV death) during the two weeks follow-up in the three groupsTimepoint: 7 days and 14 days;Change in liver function tests/parameters from baseline to Week 2. [LFT will be assessed by AST, ALT, Serum Bilirubin] in the three groupsTimepoint: 14 days;Change in renal function tests/parameters from baseline to Week 2. [KFT will be assessed by serum creatinine and blood urea nitrogen] in the three groupsTimepoint: 14 days;Gastrointestinal adverse events reported (any epigastric pain, upper GI bleeding, peptic ulcer, etc.) during the two weeks follow-up in the three groupsTimepoint: 7 days and 14 days;Other Adverse events reported during the two weeks follow-up in the three groupsTimepoint: 14 days