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

Primary Purpose

Acute Muscle Pain

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

SPARC1401-low dose

SPARC1401-mid dose

SPARC1401-high dose

Reference1401 (Tizanidine)

Placebo1401

About this trial

This is an interventional treatment trial for Acute Muscle Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Active comparator

Arm 5

Arm Description

three times medication; SPARC1401-low dose

three times medication; SPARC1401-mid dose

three times medication; SPARC1401-high dose

Reference1401; To be administered 3 times a day

Placebo1401 - 3 three times a day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02887534

First Posted

July 20, 2016

Last Updated

May 2, 2019

Sponsor

Sun Pharma Advanced Research Company Limited

1. Study Identification

Unique Protocol Identification Number

NCT02887534

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Withdrawn

Study Start Date

November 2016 (Anticipated)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sun Pharma Advanced Research Company Limited

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Muscle Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

three times medication; SPARC1401-low dose

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

three times medication; SPARC1401-mid dose

Arm Title

Arm 3

Arm Type

Experimental

Arm Description

three times medication; SPARC1401-high dose

Arm Title

Active comparator

Arm Type

Active Comparator

Arm Description

Reference1401; To be administered 3 times a day

Arm Title

Arm 5

Arm Type

Placebo Comparator

Arm Description

Placebo1401 - 3 three times a day

Intervention Type

Drug

Intervention Name(s)

SPARC1401-low dose

Other Intervention Name(s)

Test 1

Intervention Description

SPARC1401- low dose

Intervention Type

Drug

Intervention Name(s)

SPARC1401-mid dose

Other Intervention Name(s)

Test 2

Intervention Description

SPARC1401- mid dose

Intervention Type

Drug

Intervention Name(s)

SPARC1401-high dose

Other Intervention Name(s)

Test 3

Intervention Description

SPARC1401-high dose

Intervention Type

Drug

Intervention Name(s)

Reference1401 (Tizanidine)

Other Intervention Name(s)

Reference1401

Intervention Description

Reference1401 (Tizanidine) three times a day

Intervention Type

Drug

Intervention Name(s)

Placebo1401

Other Intervention Name(s)

Placebo intervention

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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

Time Frame

Day 4

Secondary Outcome Measure Information:

Title

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

Time Frame

Day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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