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

Sun Pharma Advanced Research (SPARC)

Status and phase: Withdrawn; Phase 2

Conditions: Acute Muscle Pain

Treatments: Drug: SPARC1401-mid dose; Drug: Reference1401 (Tizanidine); Drug: Placebo1401; Drug: SPARC1401-low dose; Drug: SPARC1401-high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02887534

CLR_14_01

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 5 patient groups, including a placebo group

Arm 1

Experimental group

Description:

three times medication; SPARC1401-low dose

Treatment:

Drug: SPARC1401-low dose

Drug: Placebo1401

Arm 2

Experimental group

Description:

three times medication; SPARC1401-mid dose

Treatment:

Drug: Placebo1401

Drug: SPARC1401-mid dose

Arm 3

Experimental group

Description:

three times medication; SPARC1401-high dose

Treatment:

Drug: SPARC1401-high dose

Drug: Placebo1401

Active comparator

Active Comparator group

Description:

Reference1401; To be administered 3 times a day

Treatment:

Drug: Reference1401 (Tizanidine)

Arm 5

Placebo Comparator group

Description:

Placebo1401 - 3 three times a day

Treatment:

Drug: Placebo1401