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

NCT02887534 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-05-03

No results posted yet for this study

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

Conditions

  • Acute Muscle Pain

Interventions

DRUG

SPARC1401-low dose

SPARC1401- low dose

DRUG

SPARC1401-mid dose

SPARC1401- mid dose

DRUG

SPARC1401-high dose

SPARC1401-high dose

DRUG

Reference1401 (Tizanidine)

Reference1401 (Tizanidine) three times a day

DRUG

Placebo1401

Placebo

Sponsors & Collaborators

  • Sun Pharma Advanced Research Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-12-31
Completion
2017-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02887534 on ClinicalTrials.gov