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Trial record 3 of 189 for:    1401

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2016 by Sun Pharma Advanced Research Company Limited
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT02887534
First received: July 20, 2016
Last updated: August 29, 2016
Last verified: August 2016
  Purpose
A phase 2 randomized clinical trial to evaluate efficacy and safety of SPARC1401 at three dose levels in patients with acute low back pain

Condition Intervention Phase
Acute Muscle Pain
Drug: SPARC1401-low dose
Drug: SPARC1401-mid dose
Drug: SPARC1401-high dose
Drug: Reference1401 (Tizanidine)
Drug: Placebo1401
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Active and Placebo-controlled, Study of SPARC1401 in Subjects With Moderate to Severe Acute Low Back Pain

Resource links provided by NLM:


Further study details as provided by Sun Pharma Advanced Research Company Limited:

Primary Outcome Measures:
  • Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very good, 4 - excellent [ Time Frame: Day 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very, 4 - excellent [ Time Frame: Day 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: November 2016
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
three times medication; SPARC1401-low dose
Drug: SPARC1401-low dose
SPARC1401- low dose
Other Name: Test 1
Drug: Placebo1401
Placebo
Other Name: Placebo intervention
Experimental: Arm 2
three times medication; SPARC1401-mid dose
Drug: SPARC1401-mid dose
SPARC1401- mid dose
Other Name: Test 2
Drug: Placebo1401
Placebo
Other Name: Placebo intervention
Experimental: Arm 3
three times medication; SPARC1401-high dose
Drug: SPARC1401-high dose
SPARC1401-high dose
Other Name: Test 3
Drug: Placebo1401
Placebo
Other Name: Placebo intervention
Active Comparator: Active comparator
Reference1401; To be administered 3 times a day
Drug: Reference1401 (Tizanidine)
Reference1401 (Tizanidine) three times a day
Other Name: Reference1401
Placebo Comparator: Arm 5
Placebo1401 - 3 three times a day
Drug: Placebo1401
Placebo
Other Name: Placebo intervention

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02887534

Contacts
Contact: Shravanti Bhowmik 2266455645 shravanti.bhowmik@sparcmail.com

Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  More Information

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT02887534     History of Changes
Other Study ID Numbers: CLR_14_01 
Study First Received: July 20, 2016
Last Updated: August 29, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Myalgia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Neuromuscular Diseases
Tizanidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Muscle Relaxants, Central
Neuromuscular Agents
Parasympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 23, 2016