A post marketing study to assess the safety and efficacy of Four 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: G438- Other migraineHealth Condition 4: M658- Other synovitis and tenosynovitisHealth Condition 5: S934- Sprain of ankle

• Registration Number: CTRI/2023/09/057622
• Lead Sponsor: Alkem Laboratories Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 September 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. 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: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of pain as measured by numerical <br/ ><br>rating scale as compared to baseline in the Four <br/ ><br>groupsTimepoint: 07 Days & 14 Days

Secondary Outcome Measures

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