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

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

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