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

A prospective, open-label, multicentre, active controlled, comparative, post marketing study to evaluate the safety and efficacy of FDC of nimesulide-paracetamol as compared to FDC of aceclofenac-paracetamol, ketorolac and FDC of diclofenac-paracetamol in patients with acute painful conditions

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/09/057622

Enrollment

600

Registered

2023-09-14

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G891- Acute pain, not elsewhere classified Health Condition 2: K089- Disorder of teeth and supporting structures, unspecified Health Condition 3: G438- Other migraine Health Condition 4: M658- Other synovitis and tenosynovitis Health Condition 5: S934- Sprain of ankle

Interventions

Intervention1: Nimesulide 100mg and Paracetamol 325mg tablets: one tablet to be taken twice daily every 12 hourly for maximum of 10 days Control Intervention1: Aceclofenac 100mg and Paracetamol 325mg

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Reduction of pain as measured by numerical rating scale as compared to baseline in the Four groupsTimepoint: 07 Days & 14 Days	—

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Jayesh Sanmukhani

Alkem Laboratories Limited

ajitkumar.gondane@alkem.com8983375722

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026