A Randomized, Double-blind, Active and Placebo-controlled, Study of SPARC1401 in Subjects With Moderate to Severe Acute Low Back Pain
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Primary Endpoint
- Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very good, 4 - excellent
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm 1
three times medication; SPARC1401-low dose
Intervention: SPARC1401-low dose (Drug)
Arm 1
three times medication; SPARC1401-low dose
Intervention: Placebo1401 (Drug)
Arm 2
three times medication; SPARC1401-mid dose
Intervention: SPARC1401-mid dose (Drug)
Arm 2
three times medication; SPARC1401-mid dose
Intervention: Placebo1401 (Drug)
Arm 3
three times medication; SPARC1401-high dose
Intervention: SPARC1401-high dose (Drug)
Arm 3
three times medication; SPARC1401-high dose
Intervention: Placebo1401 (Drug)
Active comparator
Reference1401; To be administered 3 times a day
Intervention: Reference1401 (Tizanidine) (Drug)
Arm 5
Placebo1401 - 3 three times a day
Intervention: Placebo1401 (Drug)
Outcomes
Primary Outcomes
Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very good, 4 - excellent
Time Frame: Day 4
Secondary Outcomes
- Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very, 4 - excellent(Day 8)