Evaluation of Efficacy and Safety of SPARC1401 in Acute Low Back Pain

Study Overview
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Brief Summary
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A phase 2 randomized clinical trial to evaluate efficacy and safety of SPARC1401 at three dose levels in patients with acute low back pain

Official Title
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A Randomized, Double-blind, Active and Placebo-controlled, Study of SPARC1401 in Subjects With Moderate to Severe Acute Low Back Pain

Conditions
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Acute Muscle Pain

Intervention / Treatment
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* Drug: SPARC1401-low dose
* Drug: SPARC1401-mid dose
* Drug: SPARC1401-high dose
* Drug: Reference1401 (Tizanidine)
* Drug: Placebo1401


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gives informed and written consent and is able to comply with all study assessments scheduled in the protocol Males or females aged 18 to 80 years (inclusive). Female subjects should be surgically sterile (bilateral tubal ligation at least 6 months prior to randomization, bilateral oophorectomy or hysterectomy performed) or if they are of child-bearing potential, should be willing to practice an acceptable method of birth control from screening to completion of study. Subjects will be considered eligible for this trial based on medical evaluation, electrocardiogram and laboratory values at screening, and laboratory values outside normal range considered of no clinical significance by the investigator Exclusion Criteria: History or presence of clinically significant or uncontrolled cardiovascular, respiratory, neurological, psychiatric, hepatic, renal, gastrointestinal, hematological, or sleep disorder History or clinical signs or symptoms suggestive of stenosing peptic ulcer, pyloroduodenal obstruction, or inflammatory bowel disease History of diagnosis of cancer within 5 years prior to screening History of narrow-angle glaucoma, symptomatic prostatic hypertrophy, or bladder-neck obstruction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>three times medication; SPARC1401-low dose | Drug: SPARC1401-low dose<br>* SPARC1401- low dose<br>* Other names: Test 1;Drug: Placebo1401<br>* Placebo<br>* Other names: Placebo intervention;|
| Experimental: Arm 2<br>three times medication; SPARC1401-mid dose | Drug: SPARC1401-mid dose<br>* SPARC1401- mid dose<br>* Other names: Test 2;Drug: Placebo1401<br>* Placebo<br>* Other names: Placebo intervention;|
| Experimental: Arm 3<br>three times medication; SPARC1401-high dose | Drug: SPARC1401-high dose<br>* SPARC1401-high dose<br>* Other names: Test 3;Drug: Placebo1401<br>* Placebo<br>* Other names: Placebo intervention;|
| Active Comparator: Active comparator<br>Reference1401; To be administered 3 times a day | Drug: Reference1401 (Tizanidine)<br>* Reference1401 (Tizanidine) three times a day<br>* Other names: Reference1401;|
| Placebo Comparator: Arm 5<br>Placebo1401 - 3 three times a day | Drug: Placebo1401<br>* Placebo<br>* Other names: Placebo intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very good, 4 - excellent |  | Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very, 4 - excellent |  | Day 8 |