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

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ClinicalTrials.gov Identifier: NCT02887534
Recruitment Status : Withdrawn
First Posted : September 2, 2016
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Estimated Study Start Date : November 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very good, 4 - excellent [ Time Frame: Day 4 ]

Secondary Outcome Measures :
  1. Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very, 4 - excellent [ Time Frame: Day 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT02887534     History of Changes
Other Study ID Numbers: CLR_14_01
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Myalgia
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
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