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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02887534

Enrollment

Registered

2016-09-02

Start date

2016-11-30

Completion date

2017-12-31

Last updated

2019-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Muscle Pain

Brief summary

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

Interventions

DRUGSPARC1401-low dose

SPARC1401- low dose

DRUGSPARC1401-mid dose

SPARC1401- mid dose

DRUGSPARC1401-high dose

SPARC1401-high dose

DRUGReference1401 (Tizanidine)

Reference1401 (Tizanidine) three times a day

DRUGPlacebo1401

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026