Evaluation of Eperisone HCl in the Treatment of Acute Musculoskeletal Spasm Associated With Low B… (NCT00327730) | Clinical Trial Compass
CompletedPhase 3
Evaluation of Eperisone HCl in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain - A Double Blind, Randomised, Placebo Controlled Clinical Trial
India240 participantsStarted 2006-04
Plain-language summary
The purpose of this study is to evaluate the efficacy of Eperisone HCl in the treatment of Acute Musculoskeletal spasm associated with Low-Back Pain.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients of either sex between 18 to 60 years of age.
. Patients with confirmed diagnosis of Acute Musculoskeletal spasm with Low Back Pain due to:
. Patients who are willing to take the medications as directed and willing to come for follow-ups.
. Patients who are willing to comply with the protocol requirements.
. Patients who are willing to give the written informed consent.
Exclusion criteria
. Patients with other associated spasm conditions like:
. Patients who had taken any form of skeletal muscle relaxant in the previous 7 days.
. Patients with hypersensitivity to any of the ingredients of the test \& control formulations.
. Pregnant/Lactating women or women of child bearing potential not following adequate contraceptive measures.
. Patients unwilling or unable to comply with the study procedures.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The present study will be conducted with an objective of comparing the efficacy of Eperisone-HCl (Myonal) versus placebo in the treatment of acute musculoskeletal spasm associated with low back pain.
. Patients having a history of severe acute infection, major surgery or trauma, severe metabolic, endocrine or electrolyte disturbances and seizures in preceding 8 weeks.
. Patients having severe renal insufficiency defined by a creatinine value above 2.5 mg/dl.
. Patients having severe hepatic insufficiency defined by an SGOT or SGPT value equal or higher than the threefold normal values of the respective laboratory reference value.