A clinical trial to study the effects of Fixed dose combination (Naproxen 500mg+ paracetamol 500 mg) in patients with acute painful/inflammatory conditions
- Registration Number
- CTRI/2010/091/001495
- Lead Sponsor
- RPG Life Science LTD, Ceat amhal, Dr annie Besant Road, worli Mumbai 4000030. Telephone; +91 22 24981650
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 210
?Male and Female patients of above 18 years and upto below 70 years of age.
?Patients with acute painful condition for a month or less.
?Patients with mild to moderate pain due to acute painful/inflammatory condition e.g. acute musculoskeletal pain, dysmenorrhoea, acute back pain, acute joint pain and dental pain)
?Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
?Male and Female patients < 18 years and > 70 years of age.
?Current pregnancy or lactation amongst females.
?History of or preexisting Hematological, Renal, Cardiac or Hepatic disease.
?History of hypersensitivity to NSAIDs / Paracetamol.
?Patients with Bronchial Asthma, Recurrent Rhinitis, Nasal Polyps.
?History of hypersensitivity to Aspirin.
?Patients with history of any of the following conditions within a period of 3 months prior to screening:
oActive esophageal and/or gastric or duodenal ulcer
oGastrointestinal bleeding
oCrohn?s disease
oUlcerative colitis
oChronic diarrhea
?Patients who have participated in any other clinical trial in the past 90 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Trial Treatment outcome measured by change in pain intensity score from baseline (day 1) to end of treatment (day 5) measured by the 0-100 mm horizontal Visual Analog Scale (VAS).Timepoint: Day 0 to Day 5
- Secondary Outcome Measures
Name Time Method <br>To evaluate the need and frequency of analgesic rescue medications (Other than Trial Treatment under study).<br>Timepoint: 0- 5 days;To evaluate Patient?s Global Assessment of Efficacy and Tolerability of trial treatment.Timepoint: 0-5 Days;To evaluate Physician?s Global Assessment for Efficacy and Tolerability of trial treatment.Timepoint: 0-5 days;To evaluate the impact of pain on Quality of Life (QoL) of patientsTimepoint: 0-5 Days;To evaluate the safety by assessing the type, number, frequency of Adverse Events AE(s) encountered with each of the three trial treatments.Timepoint: 0-5 Days