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

May 2, 2019 updated by: Sun Pharma Advanced Research Company Limited

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharma Advanced Research Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

August 29, 2016

First Posted (Estimate)

September 2, 2016

Study Record Updates

Last Update Posted (Actual)

May 3, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLR_14_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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