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

NCT02887534 | Withdrawn Phase 2

• 1 other identifier: CLR_14_01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Acute Muscle Pain

Outcome Measures

Primary Outcomes (1)

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

  Day 4

Secondary Outcomes (1)

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

  Day 8

Study Arms (5)

Arm 1

EXPERIMENTAL

three times medication; SPARC1401-low dose

Drug: SPARC1401-low dose; Drug: Placebo1401

Arm 2

EXPERIMENTAL

three times medication; SPARC1401-mid dose

Drug: SPARC1401-mid dose; Drug: Placebo1401

Arm 3

EXPERIMENTAL

three times medication; SPARC1401-high dose

Drug: SPARC1401-high dose; Drug: Placebo1401

Active comparator

ACTIVE COMPARATOR

Reference1401; To be administered 3 times a day

Drug: Reference1401 (Tizanidine)

Arm 5

PLACEBO COMPARATOR

Placebo1401 - 3 three times a day

Drug: Placebo1401

Interventions

SPARC1401-low dose DRUG

SPARC1401- low dose

Also known as: Test 1

Arm 1

SPARC1401-mid dose DRUG

SPARC1401- mid dose

Also known as: Test 2

Arm 2

SPARC1401-high dose DRUG

SPARC1401-high dose

Also known as: Test 3

Arm 3

Reference1401 (Tizanidine) DRUG

Reference1401 (Tizanidine) three times a day

Also known as: Reference1401

Active comparator

Placebo1401 DRUG

Placebo

Also known as: Placebo intervention

Arm 1; Arm 2; Arm 3; Arm 5

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Pharma Advanced Research Company Limited: lead

MeSH Terms

Interventions

tizanidine

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: September 2, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share