Muscle Spasm; Back PainPhase 3NCT00327730
Evaluation of Eperisone HCl in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain - A Double Blind, Randomised, Placebo Controlled Clinical Trial
A Phase 3 study testing Eperisone in people with Muscle Spasm; Back Pain, run by Eisai Inc. at 4 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Muscle Spasm; Back Pain
- What is being tested?
- Eperisone
- How many people
- 240 participants
- Where
- 4 sitesIndia
- Study dates
- Apr 2006to Jun 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
- Spondylosis deformans
- Prolapsed Intervertebral Disc (PID)
- Muscle sprains with spasms
- 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.
Who cannot join
- Patients with other associated spasm conditions like:
- Muscle sprains with spasms of hip/knee/ankle
- Traumatic pain with spasms
- Cervical Spondylitis
- Pain \& spasm associated with fractured bone.
- Patients who had taken any form of skeletal muscle relaxant in the previous 7 days.
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- 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.
- 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.
- Patients having any of the following disorders:
- Renal failure
- Bulimia
- Hypo and Hyperthyroidism
- Nephrotic syndrome
- Anorexia nervosa
- Biliary obstruction
- Severe cardiac dysfunction.
- Patients having uncontrolled diabetes mellitus, or any other metabolic or endocrine disorder.
- Patients that have received treatment with any investigational drug in the preceding 4 weeks.
- Patients likely to be non-compliant (alcohol, smoking or drug abusers).
- Any condition that, in the opinion of the investigator, does not justify patient's inclusion in the study.
Trial locations and contacts
4 sites in 1 country.
India4 sites
Grant Medical College Sir J.J. Group of Hospitals
Byculla, Mumbai, Maharashtra, 400 008
Post Graduate Institute of Medical Education and Research (PGI)
Chandigarh, Punjab, 160 012
M.R. Medical College
Kalaburagi, Karnataka, 585 104
L.T. M. Medical College and General Hospital
Sion, Mumbai, Maharashtra, 400 022
About this study
Official title: Evaluation of Eperisone HCl in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain
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.
Read the detailed description
This is a multi-center trial, which will be conducted in a total of 240 patients (120 patients in each treatment group). Patients attending the out-patient setting of traumatology and orthopedic departments of the study centers will be screened for lumbar pain and spasm by clinical and radiological examination for inclusion. In this study, it has been planned to enroll a total of 240 patients with 120 patients in each group. The total duration of treatment will be 14 days. Patients will be screened for baseline parameters and will then be randomized, as per the predetermined randomization schedule, into two groups. Patients will be treated with either Eperisone-HCl (Myonal) or placebo for a period of 14 days. After the baseline-screening visit (Day 1), the patients would be asked to follow up on day 3, day 7, and day 14. During each visit, a complete general examination and clinical evaluation of efficacy parameters would be done. Adverse events would be monitored during the study period and would be recorded in the Case Report Form (CRF). At the end of the treatment, Global Assessment of Response to Therapy by Physicians and Patients (PGART) would be done for efficacy and tolerability separately.
- Conditions
- Muscle Spasm; Back Pain
- Being tested
- Eperisone
- Keywords
- Muscle, Spasm, Back, Pain
- Medical subject headings
- Spasm, Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EperisoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (1)
The present study will be conducted with a secondary objective of comparing the tolerability of Eperisone-HCl (Myonal) versus placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startApr 2006
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Spasm; Back PainStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eisai Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Dr. Dilip Pawar, Study director, Eisai Pharmaceuticals India Pvt. Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327730
- Sponsor's protocol ID
- E0646-AS91-301
- Status last verified
- Apr 2014
- First submitted
- 17 May 2006
- Last updated
- 21 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Eperisone HCl in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain
- ClinicalTrials.gov ID
- NCT00327730
- Acronym / sponsor ID
- E0646-AS91-301
- Conditions
- Muscle Spasm; Back Pain
- Keywords
- Muscle, Spasm, Back, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eisai Co., Ltd.
- Study start
- Apr 2006
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 18 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center trial, which will be conducted in a total of 240 patients (120 patients in each treatment group). Patients attending the out-patient setting of traumatology and orthopedic departments of the study centers will be screened for lumbar pain and spasm by clinical and radiological examination for inclusion. In this study, it has been planned to enroll a total of 240 patients with 120 patients in each group. The total duration of treatment will be 14 days. Patients will be screened for baseline parameters and will then be randomized, as per the predetermined randomization schedule, into two groups. Patients will be treated with either Eperisone-HCl (Myonal) or placebo for a period of 14 days. After the baseline-screening visit (Day 1), the patients would be asked to follow up on day 3, day 7, and day 14. During each visit, a complete general examination and clinical evaluation of efficacy parameters would be done. Adverse events would be monitored during the study period and would be recorded in the Case Report Form (CRF). At the end of the treatment, Global Assessment of Response to Therapy by Physicians and Patients (PGART) would be done for efficacy and tolerability separately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eperisone | Drug | – |
Primary outcome
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.
1 secondary outcome
The present study will be conducted with a secondary objective of comparing the tolerability of Eperisone-HCl (Myonal) versus placebo.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Dilip Pawar study director
Eisai Pharmaceuticals India Pvt. Ltd
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eperisone in people with Muscle Spasm; Back Pain, run by Eisai Inc. at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.