A study designed to assess how safe, well-tolerated, and effective a combination of two medicines, Nimesulide and Paracetamol, is for people with long-term pain.

A prospective, single arm, post-marketing, investigator-initiated study to evaluate safety, tolerability and efficacy of fixed dose combination (FDC) of Nimesulide and Paracetamol in patients with chronic painful conditions - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/02/080922

Enrollment

100

Registered

2025-02-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: G892- Chronic pain, not elsewhere classified

Interventions

Intervention1: Nimesulide (100mg) + Paracetamol (325mg) tablets: One tablet of Nimesulide (100mg) + Paracetamol (325mg) tablets twice daily for 3 to 4 weeks Control Intervention1: Not Applicable: Not

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either gender more than 18 years of age 2. Patients with chronic painful conditions such as osteoarthritis knee, OA hip, frozen shoulder, bursitis, chronic ligament injury / sprain requiring treatment with FDC of nimesulide-paracetamol for 3 to 4 weeks time as per routine clinical practice 3. Patients willing to 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 more 3 x Upper Normal Limit) or renal dysfunction (serum creatinine more 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
Change in liver function (AST, ALT, Serum Bilirubin) tests, Change in renal function, change in heart burn scoreTimepoint: from baseline to Week 1 / 2 / 3 and 4.	—

Secondary

Measure	Time frame
Reduction of pain as measured by the numerical rating scale (NRS)Timepoint: at the end of week 1, week 2, week 3 and week 4	—

Countries

India

Contacts

Public ContactDr Jayesh Sanmukhani

Clinexcel Research

drjayesh@clinexcelresearch.com7600012192

Outcome results

None listed

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