Evaluation of efficacy and safety of aceclofenac injection in the treatment of acute lumbago: a randomised comparative open-labeled multi-centric trial

Completed

Conditions: Acute Lumbago
Musculoskeletal Diseases
Pain

Registration Number: ISRCTN99850066

Lead Sponsor: Venus Remedies Limited (India)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 300

Inclusion Criteria

1. Patients of either sex, aged over 18 years suffering from acute lumbago (that began less than 48 hours before study entry)
2. Pain intensity more than 50 mm on a 100 mm Visual Analogue Scale (VAS)

Exclusion Criteria

Patients with history of:
1. Recurrent peptic ulcer or duodenal ulcer
2. Gastrointestinal bleeding or other bleeding disorders
3. Significant renal or hepatic impairment
4. Any significant abnormality on preclinical trial screening
5. Pregnant and lactating mothers
6. Patients requiring aspirin at any dose, corticosteroids, anticoagulants, ticlopidine hydrochloride or other drugs affecting platelet function and coagulation, and patients taking hormonal contraceptives or patients allergic to Non Steroidal Anti-Inflammatory Drugs (NSAIDs)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Assessment of overall response to study drugs.<br>2. Assessment of overall response of subjects to the drug.

Secondary Outcome Measures

Name	Time	Method
1. Assessment of changes in VAS pain at 30 minutes, one, two, four, eight, 24 and 48 hours after the treatment compared with the baseline.<br>2. Assessment to degree of improvement after eight hours, 24 hours and 48 hours of treatment compared to baseline in:<br>a. pain on movement using a four point scale <br>b. functional impairment using a four point scale <br>c. pain on pressure in the lumbosacral region using a four point scale <br>d. muscle contraction in the lumbosacral region using a four point scale