A clinical trial to study the effects of Fixed dose combination (Naproxen 500mg+ paracetamol 500 mg) in patients with acute painful/inflammatory conditions

A Phase III, Three Arm, Double Blind, Randomized, Multi-centric, Comparative Superiority Study To Evaluate The Efficacy And Safety Of A Fixed Dose Combination (Naproxen 500mg + Paracetamol 500mg) In Comparison With Naproxen 500mg Or Paracetamol 500mg Given Alone For Short Term Management Of Acute Painful/Inflammatory Conditions

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001495

Enrollment

210

Registered

2010-12-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Naproxen500mg+ Paracetamol 500mg: BID for 5 days Control Intervention1: Naproxen 500 mg: BID for 5 days Control Intervention2: Paracetamol 500 mg: BID for 5 Days

Eligibility

Inclusion criteria

Inclusion criteria: ? 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.

Exclusion criteria

Exclusion criteria: ? 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: o Active esophageal and/or gastric or duodenal ulcer o Gastrointestinal bleeding o Crohn?s disease o Ulcerative colitis o Chronic diarrhea ? Patients who have participated in any other clinical trial in the past 90 days.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To evaluate the need and frequency of analgesic rescue medications (Other than Trial Treatment under study). 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	—

Measure

Time frame

To evaluate the need and frequency of analgesic rescue medications (Other than Trial Treatment under study). 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

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Countries

India

Contacts

Public ContactSohal Vaidya

Medical advisor

amita.birla@rpgls.com+91 22 24981650

Outcome results