Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-02 @ 7:43 AM
Study NCT ID:
NCT02887534
Status:
WITHDRAWN
Last Update Posted:
2019-05-03
First Post:
2016-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Efficacy and Safety of SPARC1401 in Acute Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C023754', 'term': 'tizanidine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-02', 'studyFirstSubmitDate': '2016-07-20', 'studyFirstSubmitQcDate': '2016-08-29', 'lastUpdatePostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very good, 4 - excellent', 'timeFrame': 'Day 4'}], 'secondaryOutcomes': [{'measure': 'Rating for medication helpfulness on five point scale: 0 - poor, 1 - fair, 2 - good, 3 - very, 4 - excellent', 'timeFrame': 'Day 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Muscle Pain']}, 'descriptionModule': {'briefSummary': 'A phase 2 randomized clinical trial to evaluate efficacy and safety of SPARC1401 at three dose levels in patients with acute low back pain'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gives informed and written consent and is able to comply with all study assessments scheduled in the protocol\n* Males or females aged 18 to 80 years (inclusive).\n* 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.\n* 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\n\nExclusion Criteria:\n\n* History or presence of clinically significant or uncontrolled cardiovascular, respiratory, neurological, psychiatric, hepatic, renal, gastrointestinal, hematological, or sleep disorder\n* History or clinical signs or symptoms suggestive of stenosing peptic ulcer, pyloroduodenal obstruction, or inflammatory bowel disease\n* History of diagnosis of cancer within 5 years prior to screening\n* History of narrow-angle glaucoma, symptomatic prostatic hypertrophy, or bladder-neck obstruction'}, 'identificationModule': {'nctId': 'NCT02887534', 'briefTitle': 'Evaluation of Efficacy and Safety of SPARC1401 in Acute Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharma Advanced Research Company Limited'}, 'officialTitle': 'A Randomized, Double-blind, Active and Placebo-controlled, Study of SPARC1401 in Subjects With Moderate to Severe Acute Low Back Pain', 'orgStudyIdInfo': {'id': 'CLR_14_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'three times medication; SPARC1401-low dose', 'interventionNames': ['Drug: SPARC1401-low dose', 'Drug: Placebo1401']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'three times medication; SPARC1401-mid dose', 'interventionNames': ['Drug: SPARC1401-mid dose', 'Drug: Placebo1401']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'three times medication; SPARC1401-high dose', 'interventionNames': ['Drug: SPARC1401-high dose', 'Drug: Placebo1401']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active comparator', 'description': 'Reference1401; To be administered 3 times a day', 'interventionNames': ['Drug: Reference1401 (Tizanidine)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 5', 'description': 'Placebo1401 - 3 three times a day', 'interventionNames': ['Drug: Placebo1401']}], 'interventions': [{'name': 'SPARC1401-low dose', 'type': 'DRUG', 'otherNames': ['Test 1'], 'description': 'SPARC1401- low dose', 'armGroupLabels': ['Arm 1']}, {'name': 'SPARC1401-mid dose', 'type': 'DRUG', 'otherNames': ['Test 2'], 'description': 'SPARC1401- mid dose', 'armGroupLabels': ['Arm 2']}, {'name': 'SPARC1401-high dose', 'type': 'DRUG', 'otherNames': ['Test 3'], 'description': 'SPARC1401-high dose', 'armGroupLabels': ['Arm 3']}, {'name': 'Reference1401 (Tizanidine)', 'type': 'DRUG', 'otherNames': ['Reference1401'], 'description': 'Reference1401 (Tizanidine) three times a day', 'armGroupLabels': ['Active comparator']}, {'name': 'Placebo1401', 'type': 'DRUG', 'otherNames': ['Placebo intervention'], 'description': 'Placebo', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3', 'Arm 5']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharma Advanced Research Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}