Who is sponsoring NCT01300312?

NCT01300312 is sponsored by Eisai Co., Ltd..

What condition does NCT01300312 study?

NCT01300312 studies Acute Musculoskeletal Spasm Due to Low Back Pain.

What drugs are being tested in NCT01300312?

Interventions: Eperisone hydrochloride and Diclofenac sodium, Eperisone hydrochloride.

What is the status of NCT01300312?

NCT01300312 is currently COMPLETED.

Last reviewed 2013-01-04 · How we verify

Evaluation of Efficacy and Tolerability of a Fixed Dose Combination of Eperisone Hydrochloride and Diclofenac Sodium in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain: An Observer Blind, Prospective, Randomized, Controlled Study

NCT01300312 Phase 3 COMPLETED

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.

Details

Lead sponsor	Eisai Co., Ltd.
Phase	Phase 3
Status	COMPLETED
Enrolment	239
Start date	2011-02
Completion	2011-09

Conditions

Acute Musculoskeletal Spasm Due to Low Back Pain

Interventions

Eperisone hydrochloride and Diclofenac sodium
Eperisone hydrochloride

Primary outcomes

Finger to Floor Distance: Improvement in Finger to Floor Distance compared to baseline. — Day 1,3,7 and 10 of study period
Improvement in the Fingertip-to-Floor-surface Distance \[FFD\] from baseline on Day 3, Day 7 \& Day 10. Finger Floor Distance \[FFD\] is an index for the mobility of the lumbar spinal cord and is measured as the distance between the finger-tip of the middle Finger to the Floor-surface as determined while standing with the spinal cord flexed with complete extension of knee joint. It is measured in millimeters.

Countries

India