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A Clinical Trial to Study the Effects of a Fixed Dose Combination of Diclofenac and Eperisone Hydrochloride With Plain Eperisone Hydrochloride in Patients With Low Back Pain

NCT01300312 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2013-01-08

No results posted yet for this study

Summary

The purpose of this study is to investigate the effects of a fixed dose combination of diclofenac and eperisone hydrochloride compared with plain eperisone hydrochloride in patients with low back pain.

Conditions

  • Acute Musculoskeletal Spasm Due to Low Back Pain

Interventions

DRUG

Eperisone hydrochloride and Diclofenac sodium

Fixed dose capsule formulation of eperisone hydrochloride 50 mg plus diclofenac sodium 50 mg to be given 3 times a day after meals for 7 to 10 days

DRUG

Eperisone hydrochloride

eperisone hydrochloride 50 mg as tablet formulation to be given 3 times daily after meals for 7 to 10 days

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Suyog Mehta · General Manager - Medical and Regulatory Affairs, Eisai Pharmaceuticals India Private Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-06-30
Completion
2011-09-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01300312 on ClinicalTrials.gov