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Completed

NCT Number: NCT01806818

Comparing Efficacy and Safety Between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients

Multi-center Study to Compare Efficacy and Safety between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients during 7 days.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hallym University Sacred Heart Hospital, Anyang, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing
  • 20≤ age ≤60
  • A patient has symptom of acute low back pain
  • 4≤ VAS

Exclusion criteria

  • Subjects who cannot prohibit anti-inflammatory drug, painkiller or muscle relaxants during clinical trial
  • Chronic rheumatoid arthritis patients
  • Patients having a medical history of hypersensitivity to Eperisone Hydrochloride
  • Subject having a hereditary problem such as galactose intolerance, Lapp lactase deficiency, or glucose galatose malabsorption
  • Participation in other studies before 60 days of first dosing
  • Female patients having positive pregnancy test, lactating women,planning pregnancy during clinical trial
  • Inadequate subject for the clinical trial by the investigator's decision

Treatment and study plan

Epirisone 50mg or placebo TID

Drug

3 times a day after meals for 1 week

Primary outcomes

  1. VAS improvement of pain at rest, on movement and at night

    Time frame: 7 days

Secondary outcomes

  1. Change of Modified Schober test

    Time frame: 7 days

  2. Change of Lateral Body Bending test

    Time frame: 7 days

  3. Change of EuroQol by patients

    Time frame: 7 days

  4. Change of Oswestry Disability Index

    Time frame: 7 days

  5. Overall pain improvement by investigator

    Time frame: at last visit (D7+2)

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-blind, Parallel, Placebo-controlled, Multi-center Study to Compare Efficacy and Safety Between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 7, 2013
Registry last updated
Aug 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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