Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT01482858
Status:
WITHDRAWN
Last Update Posted:
2024-02-28
First Post:
2011-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analgesic Effects of the Gastrolith, in Osteoporotic Patients Suffering From Recent Skeletal Pain Caused by Vertebral Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': "In this study the oral calcium treatments are blinded. The subjects, the investigators and any personnel involved in subjects' assessment, monitoring, analysis and data management will be blinded to the subject formulation assignment except the Sponsor who will be responsible for preparing, dispensing and labeling the investigational product IP. Blinded labels will be affixed to the vials prior to dosing by the un-blinded Sponsor."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective randomized double-blind multicenter study evaluating the safety of GASP and its analgesic effect on pain resulting from OCVF following oral administration of GASP vs. placebo.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-25', 'studyFirstSubmitDate': '2011-11-29', 'studyFirstSubmitQcDate': '2011-11-30', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of pain assessed by change in NRS from baseline to end of the trial', 'timeFrame': 'from baseline to end of the trial', 'description': '• Change from baseline to end-of-trial on NRS during movement (scale of 0 to 10) computed as follows.\n\nNRSchange = NRS42 - NRS0 NRS42 - NRS score at day 42 (end-of-trial) NRS0 - NRS score at day 0 (baseline)'}], 'secondaryOutcomes': [{'measure': 'Reduction of pain assessed by change in BPI from baseline to end-of-trial', 'timeFrame': 'baseline to end-of-trial', 'description': 'The BPI uses 0 to 10 numeric rating scales for item rating because of its simplicity, lack of ambiguity and seemed the best to use for cross-linguistic pain measurement. Since pain can be quite variable over a day, the BPI asks subjects to rate their pain at the time of responding to the questionnaire (pain now), and also at its worst, least, and average over the previous week. The ratings can also be made for the last 24 hours.'}, {'measure': 'Reduction of disability assessed by change in ODI from baseline to end-of-trial', 'timeFrame': 'baseline to end-of-trial', 'description': 'Oswestry Low Back Pain Disability Questionnaire - comprises of 10 sections describing the pain and its impact, each scored from 0 to 5 with higher values indicating more severe impact.'}, {'measure': 'Reduction of ASOC assessed by weekly change in analgesic consumption diaries from baseline to end of trial', 'timeFrame': 'baseline to end of trial', 'description': "Analgesic drug consumption will be daily self-recorded by subjects in a diary bearing drug's name and daily dose. The number of tablets taken each day will be noted in each category."}, {'measure': 'All adverse events and serious adverse events will be collected and reported', 'timeFrame': 'Baseline until four (4) weeks after completion of the study.', 'description': 'An adverse event is any untoward medical sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of the IPs whether or not considered as IP related. A new condition or the worsening of a pre-existing condition will be considered an AE. All abnormal findings considered to be clinically significant must be recorded as adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the safety and analgesic effect (efficacy) of Gastrolith powder (GASP) on skeletal pain caused by osteoporotic vertebral compression fractures (OVCF) versus placebo, primarily as assessed by the Numeric Rating Scale (NRS), and Brief Pain Inventory (BPI). It is also intended to evaluate disability change with the Oswestry Low Back Pain Disability Index (ODI) and to evaluate whether GASP consumption leads to reduction in analgesic standard of care (ASOC) versus placebo, using weekly analgesic consumption diaries.', 'detailedDescription': 'Eighty (80) Osteoporotic subjects with recent reported severe back pain caused by OVCF will be blindly randomized into two groups (n=40 each). One group will receive GASP and the other Placebo.\n\nThe analgesic effect of GASP on top of the ASOC will be evaluated using weekly NRS and BPI assessments and three ODI questionnaires. Daily ASOC consumption will be monitored using weekly analgesic consumption diaries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteoporotic patients aged 18-80 years old, inclusive.\n* Diagnosed Osteoporotic vertebral compression fracture(s) in at least one vertebra caused by an atraumatic event or a minimal traumatic event such as falling from standing height or less, or by other minimal trauma besides a fall (see section 4.2 Table I for definitions), and visible by either X-ray radiography, CT or MRI.\n* At least six (6) weeks and no more than six (6) months from the onset of severe back pain suspected to be caused by the OVCF.\n* Presenting a score of ≥5 in the pain NRS during movement (getting up from a chair).\n* Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.\n* Subject that had signed the ICF.\n\nExclusion Criteria:\n\n* More than six (6) months from the onset of severe back pain suspected to be caused by OVCF.Subjects after vertebroplasty or kyphoplasty.\n* Hypercalcemic subjects (calcium \\> 10.50 mg/dL).\n* Subjects with renal diseases.\n* Subjects with active malignancy or other active metabolic bone disease which is not osteoporosis.\n* Subjects with cognitive impairments.\n* Pregnant or breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT01482858', 'briefTitle': 'Analgesic Effects of the Gastrolith, in Osteoporotic Patients Suffering From Recent Skeletal Pain Caused by Vertebral Fractures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amorphical Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study Evaluating the Analgesic Effects of the Gastrolith, in Osteoporotic Patients Suffering From Recent Skeletal Pain Caused by Vertebral Fractures', 'orgStudyIdInfo': {'id': 'AMCS-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gastrolith', 'description': 'Gelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use.', 'interventionNames': ['Dietary Supplement: Gastrolith']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Gelatin capsules, each containing 500 mg \\[comprised of 312.5 mg calcium carbonate (125 ±5 mg elemental calcium) and 187.5 mg of sucrose\\] for oral use as placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Gastrolith', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Gelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use.', 'armGroupLabels': ['Gastrolith']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Gelatin capsules, each containing 500 mg \\[comprised of 312.5 mg calcium carbonate (125 ±5 mg elemental calcium) and 187.5 mg of sucrose\\] for oral use as placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'country': 'Israel', 'facility': 'Clalit Health Services - South District', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Ein Carem', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Eliad Davidson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Ein Carem Medical Center, Jerusalem, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amorphical Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}