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
Overview
- Phase
- Post Marketing Surveillance
- Status
- Not yet recruiting
- Sponsor
- Dr. Prateek Lodha
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in liver function (AST, ALT, Serum Bilirubin) tests, Change in renal function, change in heart burn score
Overview
Brief Summary
In this study, patients with chronic painful conditions (osteoarthritis knee, OA hip, frozen shoulder, bursitis, chronic ligament injury / sprain) will be prescribed with FDC of nimesulide-paracetamol according to the investigator’s discretion as per routine clinical practice. The patients will be followed up on an outpatient basis on Day 7 (Visit 2), Day 14 (Visit 3), Day 21 (Visit 4), and Day 28 (Visit 5). Visit 4 or Visit 5 may be considered the end of-study visit, depending on the duration of treatment required by the patient. Primary endpoints of the study are change in liver, renal and Heart burn score from baseline to week 1,2,3 and 4. For the effectiveness reduction of pain measured by NRS scale at the end of week 1,2,3 and 4.
Study Design
- Study Type
- Pms
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either gender more than 18 years of age
- •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
- •Patients willing to provide written informed consent.
Exclusion Criteria
- •Patients with past history of hypersensitivity to study drugs
- •Patients who have used NSAIDS or any other analgesic in last 24 hours
- •Patients with history of GI bleeding
- •Patients with clinically significant uncontrolled cardiovascular disease
- •Patients with hepatic dysfunction (serum transaminases more 3 x Upper Normal Limit) or renal dysfunction (serum creatinine more 2.5 mg/dl) at screening
- •Pregnant and lactating mothers and women of child bearing potential who are not taking adequate contraceptive measures
- •Patients prescribed / require any other medication known to interact with the study medication.
- •Any other reason for which the investigator feels that the patient should not participate.
Outcomes
Primary Outcomes
Change in liver function (AST, ALT, Serum Bilirubin) tests, Change in renal function, change in heart burn score
Time Frame: from baseline to Week 1 / 2 / 3 and 4.
Secondary Outcomes
- Reduction of pain as measured by the numerical rating scale (NRS)(at the end of week 1, week 2, week 3 and week 4)
Investigators
Dr Jayesh Sanmukhani
Clinexcel Research