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

Phase 2

Withdrawn

• Conditions: Acute Muscle Pain
• Interventions: Drug: Placebo1401; Drug: SPARC1401-high dose; Drug: SPARC1401-mid dose; Drug: SPARC1401-low dose; Drug: Reference1401 (Tizanidine)

• Registration Number: NCT02887534
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-09-02
• Study Start: 2016-11
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 5	Placebo1401	Placebo1401 - 3 three times a day
Arm 3	SPARC1401-high dose	three times medication; SPARC1401-high dose
Arm 2	SPARC1401-mid dose	three times medication; SPARC1401-mid dose
Arm 2	Placebo1401	three times medication; SPARC1401-mid dose
Arm 1	Placebo1401	three times medication; SPARC1401-low dose
Arm 1	SPARC1401-low dose	three times medication; SPARC1401-low dose
Arm 3	Placebo1401	three times medication; SPARC1401-high dose
Active comparator	Reference1401 (Tizanidine)	Reference1401; To be administered 3 times a day

Primary Outcome Measures

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

Secondary Outcome Measures

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