Acute Musculoskeletal Spasm Due to Low Back PainPhase 3NCT01300312
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
A Phase 3 study testing Eperisone hydrochloride and Diclofenac sodium and Eperisone hydrochloride in people with Acute Musculoskeletal Spasm Due to Low Back Pain, run by Eisai Co., Ltd. at 4 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Musculoskeletal Spasm Due to Low Back Pain
- What is being tested?
- Eperisone hydrochloride and Diclofenac sodium and Eperisone hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 4 sitesIndia
- Study dates
- Feb 2011to Sep 2011
- 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
- Patient of either sex between 18 to 60 years of age
- Patients with confirmed diagnosis of Acute Musculoskeletal spasm with Low
- Back Pain due to any of the following causes:
- Spondylosis deformans
- Prolapsed Intervertebral Disc (PID)
- Muscle Sprains with spasms
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- Patients willing to take the medications as directed and willing to come for the follow-ups
- Willing to comply with the protocol requirements
- Willing to give the written informed consent
Who cannot join
- Patients associated with other lumbar spinal tract conditions such as spondylitis, fracture, cancers, severe arthritis and osteoporosis.
- Muscular diseases such as myositis, poliomyelitis, muscular dystrophy and myotonia.
- Other known systemic diseases affecting the neurological or endocrine.
- Patients with moderate to severe hepatic impairment (defined as increase in serum bilirubin, serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) by >2.5 times the upper reference level of the laboratory values) and renal impairment (defined as increase in serum creatinine and Blood urea nitrogen by >2.5 times the upper reference level of the laboratory values).
- Patients who had taken any form of skeletal muscle relaxant in the previous 7 days.
- Pregnant / Lactating woman or women of child bearing potential not following adequate contraceptive measures.
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- Patients with known hypersensitivity to ingredients of study/active comparators.
- Patients with any previous history of or current episode of cardio-vascular disorders.
- Subject known to be having any of the following disorder: renal failure, bulimia, hypo and hyperthyroidism, nephrotic syndrome, anorexia nervosa, biliary obstruction, severe cardiac dysfunction.
- Uncontrolled diabetes mellitus or any other metabolic disorder.
- Pediatric and pregnant patients.
- Patients with history of alcoholic/substance abuse.
- Treatment with any investigational drug in the preceding 4 weeks.
- Patients with active or recent history of, inflammatory diseases of the gastrointestinal tract such as peptic ulcer, gastritis, regional enteritis, or ulcerative colitis.
- Patients in whom acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory agents (NSAIDs) have induced asthma, rhinitis, urticaria or other allergic manifestations.
- Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study.
Trial locations and contacts
4 sites in 1 country.
India4 sites
Department of Orthopedics, Government Medical College
Chhatrapati Sambhajinagar, Maharashtra, 431001
Deore Hospital
Chhatrapati Sambhajinagar, Maharashtra
Department of Orthopedics, Grant Medical College and Sir J.J. Group of Hospitals
Mumbai, Maharashtra, 400008
Kabre Orthopedic, Spine & Dental Care
Pune, Maharashtra, 411009
About this study
Official title: 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
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.
Read the detailed description
This study is an observer-blind, prospective randomized, controlled study to evaluate efficacy and safety of fixed dose combination of eperisone hydrochloride 50 mg and diclofenac sodium 50 mg three times daily with plain eperisone hydrochloride 50 mg three times daily in patients with musculoskeletal spasm associated with low back pain. A total of 240 adult patients of either sex, 120 patients in each arm, who fulfill the inclusion and exclusion criteria will be included in this study. The patients will be evaluated at Days 3, 7 and 10 of the study visit for efficacy and safety. The efficacy evaluation includes objective parameters like Finger-to-Floor distance, Lasegue's sign, tenderness of par vertebral muscles, lumbar and dorsal hypermyotonia, leg tendon reflexes, need for rescue medication and subjective parameters like improvement in lumbar cinesalgia, pain in lower extremities, sensory disturbances of lower limb, and Global Assessment of Response to Therapy (PGART). Patients will be evaluated for safety on the clinical adverse events reported during the study period, sedation on drowsy alert scale and Global Assessment of Tolerability to Therapy (PGATT). The patients will also be evaluated for laboratory safety as assessed by measuring laboratory parameters for hemogram, renal and hepatic parameters.
- Being tested
- Eperisone hydrochloride and Diclofenac sodium, Eperisone hydrochloride
- Keywords
- eperisone, diclofenac, low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eperisone hydrochloride and Diclofenac sodiumDrug
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
Eperisone hydrochlorideDrug
eperisone hydrochloride 50 mg as tablet formulation to be given 3 times daily after meals for 7 to 10 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Eperisone hydrochloride and Diclofenac sodium |
| 2 | Active comparator | Not described Receives: Drug: Eperisone hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finger to Floor Distance: Improvement in Finger to Floor Distance compared to baseline.
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.
Measured: Day 1,3,7 and 10 of study period
Secondary outcomes (2)
Objective Efficacy Assessment: Improvement in Lasegue's sign compared to baseline
Lasegue's sign is the lumbar pain [or exacerbation of existing pain] experienced by the patient on passive movement of the legs during flexion of hip joint i.e. passive straight leg raising. It is assessed as either 'Positive' or 'Negative' sign.
Measured: Day 1, 3, 7 and 10 of study period
Subjective Efficacy Assessment: Improvement of lumbar cinesalgia compared to baseline
Improvement in Lumbar Cinesalgia (pain in lumbar region) assessed on a 0 to 100mm Visual Analogue Scale (VAS) with '0' representing 'NO PAIN' and 100 representing 'SEVERE INTOLERABLE PAIN'
Measured: Day 1, 3, 7 and 10 of study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Musculoskeletal Spasm Due to Low Back PainStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suyog Mehta, Study director, General Manager - Medical and Regulatory Affairs, Eisai Pharmaceuticals India Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300312
- Sponsor's protocol ID
- EIL/EPD/CT/01/2010
- Status last verified
- Jan 2013
- First submitted
- 14 Feb 2011
- Last updated
- 8 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01300312
- Acronym / sponsor ID
- EIL/EPD/CT/01/2010
- Keywords
- eperisone, diclofenac, low back pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 21 Feb 2011 (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 investigate the effects of a fixed dose combination of diclofenac and eperisone hydrochloride compared with plain eperisone hydrochloride in patients with low back pain.
Detailed description
This study is an observer-blind, prospective randomized, controlled study to evaluate efficacy and safety of fixed dose combination of eperisone hydrochloride 50 mg and diclofenac sodium 50 mg three times daily with plain eperisone hydrochloride 50 mg three times daily in patients with musculoskeletal spasm associated with low back pain. A total of 240 adult patients of either sex, 120 patients in each arm, who fulfill the inclusion and exclusion criteria will be included in this study. The patients will be evaluated at Days 3, 7 and 10 of the study visit for efficacy and safety. The efficacy evaluation includes objective parameters like Finger-to-Floor distance, Lasegue's sign, tenderness of par vertebral muscles, lumbar and dorsal hypermyotonia, leg tendon reflexes, need for rescue medication and subjective parameters like improvement in lumbar cinesalgia, pain in lower extremities, sensory disturbances of lower limb, and Global Assessment of Response to Therapy (PGART). Patients will be evaluated for safety on the clinical adverse events reported during the study period, sedation on drowsy alert scale and Global Assessment of Tolerability to Therapy (PGATT). The patients will also be evaluated for laboratory safety as assessed by measuring laboratory parameters for hemogram, renal and hepatic parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Eperisone hydrochloride and Diclofenac sodium |
| 2 | Active comparator | Drug: Eperisone hydrochloride |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patient of either sex between 18 to 60 years of age
- Patients with confirmed diagnosis of Acute Musculoskeletal spasm with Low
- Spondylosis deformans
- Prolapsed Intervertebral Disc (PID)
- Muscle Sprains with spasms
Key exclusion criteria (16 listed)
- Patients associated with other lumbar spinal tract conditions such as spondylitis, fracture, cancers, severe arthritis and osteoporosis.
- Muscular diseases such as myositis, poliomyelitis, muscular dystrophy and myotonia.
- Other known systemic diseases affecting the neurological or endocrine.
- Patients with moderate to severe hepatic impairment (defined as increase in serum bilirubin, serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) by >2.5 times the upper reference level of the laboratory values) and renal impairment (defined as increase in serum creatinine and Blood urea nitrogen by >2.5 times the upper reference level of the laboratory values).
- Patients who had taken any form of skeletal muscle relaxant in the previous 7 days.
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 hydrochloride and Diclofenac sodiumFixed 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 | 1 |
| Eperisone hydrochlorideeperisone hydrochloride 50 mg as tablet formulation to be given 3 times daily after meals for 7 to 10 days | Drug | 2 |
Primary outcome
Finger to Floor Distance: Improvement in Finger to Floor Distance compared to baseline.
Time frame: 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.
2 secondary outcomes
Objective Efficacy Assessment: Improvement in Lasegue's sign compared to baseline
Time frame: Day 1, 3, 7 and 10 of study period
Subjective Efficacy Assessment: Improvement of lumbar cinesalgia compared to baseline
Time frame: Day 1, 3, 7 and 10 of study period
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 8 Jan 2013.
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.
Suyog Mehta study director
General Manager - Medical and Regulatory Affairs, Eisai Pharmaceuticals India Private Limited
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 hydrochloride and Diclofenac sodium and Eperisone hydrochloride in people with Acute Musculoskeletal Spasm Due to Low Back Pain, run by Eisai Co., Ltd. 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 9 inclusion and 16 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 8 Jan 2013. 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?
Finger to Floor Distance: Improvement in Finger to Floor Distance compared to baseline. (time frame: Day 1,3,7 and 10 of study period). 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 8 Jan 2013.