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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-12-31

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

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Detailed Description

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Conditions

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Acute Muscle Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

three times medication; SPARC1401-low dose

Group Type EXPERIMENTAL

SPARC1401-low dose

Intervention Type DRUG

SPARC1401- low dose

Placebo1401

Intervention Type DRUG

Placebo

Arm 2

three times medication; SPARC1401-mid dose

Group Type EXPERIMENTAL

SPARC1401-mid dose

Intervention Type DRUG

SPARC1401- mid dose

Placebo1401

Intervention Type DRUG

Placebo

Arm 3

three times medication; SPARC1401-high dose

Group Type EXPERIMENTAL

SPARC1401-high dose

Intervention Type DRUG

SPARC1401-high dose

Placebo1401

Intervention Type DRUG

Placebo

Active comparator

Reference1401; To be administered 3 times a day

Group Type ACTIVE_COMPARATOR

Reference1401 (Tizanidine)

Intervention Type DRUG

Reference1401 (Tizanidine) three times a day

Arm 5

Placebo1401 - 3 three times a day

Group Type PLACEBO_COMPARATOR

Placebo1401

Intervention Type DRUG

Placebo

Interventions

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SPARC1401-low dose

SPARC1401- low dose

Intervention Type DRUG

SPARC1401-mid dose

SPARC1401- mid dose

Intervention Type DRUG

SPARC1401-high dose

Intervention Type DRUG

Reference1401 (Tizanidine)

Reference1401 (Tizanidine) three times a day

Intervention Type DRUG

Placebo1401

Placebo

Intervention Type DRUG

Other Intervention Names

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Test 1 Test 2 Test 3 Reference1401 Placebo intervention

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No