Analgesic Effects of the Gastrolith, in Osteoporotic Patients Suffering From Recent Skeletal Pain Caused by Vertebral Fractures
This study is not yet open for participant recruitment.
Verified November 2011 by Amorphical Ltd.
Sponsor:
Amorphical Ltd.
Information provided by (Responsible Party):
Amorphical Ltd.
ClinicalTrials.gov Identifier:
NCT01482858
First received: November 29, 2011
Last updated: November 30, 2011
Last verified: November 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis |
Dietary Supplement: Gastrolith Other: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Amorphical Ltd.:
Primary Outcome Measures:
- Reduction of pain assessed by change in NRS from baseline to end of the trial [ Time Frame: from baseline to end of the trial ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Reduction of pain assessed by change in BPI from baseline to end-of-trial [ Time Frame: baseline to end-of-trial ] [ Designated as safety issue: No ]
- Reduction of disability assessed by change in ODI from baseline to end-of-trial [ Time Frame: baseline to end-of-trial ] [ Designated as safety issue: No ]
- Reduction of ASOC assessed by weekly change in analgesic consumption diaries from baseline to end of trial [ Time Frame: baseline to end of trial ] [ Designated as safety issue: No ]
- All adverse events and serious adverse events will be collected and reported [ Time Frame: Baseline until four (4) weeks after completion of the study. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Gastrolith
Gelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use.
|
Dietary Supplement: Gastrolith
Gelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use.
|
|
Placebo Comparator: Placebo
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
|
Other: Placebo
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Osteoporotic patients aged 18-80 years old, inclusive.
- 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.
- 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.
- Presenting a score of ≥5 in the pain NRS during movement (getting up from a chair).
- Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Subject that had signed the ICF.
Exclusion Criteria:
- More than six (6) months from the onset of severe back pain suspected to be caused by OVCF.Subjects after vertebroplasty or kyphoplasty.
- Hypercalcemic subjects (calcium > 10.50 mg/dL).
- Subjects with renal diseases.
- Subjects with active malignancy or other active metabolic bone disease which is not osteoporosis.
- Subjects with cognitive impairments.
- Pregnant or breastfeeding women.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482858
Contacts
| Contact: Galit Shaltiel-Glod, PhD | 972 (0)8-6479411- | galits@amorphical.com |
Locations
| Israel | |
| Soroka Medical Center | Not yet recruiting |
| Be'er Sheva, Israel | |
| Contact: Pesach Shwartzman, MD 972-(0)8-6477433 | |
| Principal Investigator: Pesach Shwartzman, MD | |
| Clalit Health Services - South District | Not yet recruiting |
| Be'er Sheva, Israel | |
| Contact: Pesach Shwartzman, MD 972-(0)8-6477433 | |
| Principal Investigator: Pesach Shwartzman, MD | |
| Rambam Medical Center | Not yet recruiting |
| Haifa, Israel | |
| Contact: Tsofia Ish-Shalom, MD 972-(0)4-8541533 | |
| Principal Investigator: Tsofia Ish-Shalom, MD | |
| Hadassah Ein Carem | Not yet recruiting |
| Jerusalem, Israel | |
| Contact: Eliad Davidson, MD 972-(0)2-6776911 | |
| Principal Investigator: Eliad Davidson, MD | |
| Sourasky Medical Center | Not yet recruiting |
| Tel Aviv, Israel | |
| Contact: Sylvio Brill, MD 972-(0)3-6974581 | |
| Principal Investigator: Sylvio Brill, MD | |
Sponsors and Collaborators
Amorphical Ltd.
Investigators
| Principal Investigator: | Eliad Davidson, MD | Hadassah Ein Carem Medical Center, Jerusalem, Israel |
More Information
No publications provided
| Responsible Party: | Amorphical Ltd. |
| ClinicalTrials.gov Identifier: | NCT01482858 History of Changes |
| Other Study ID Numbers: | AMCS-003 |
| Study First Received: | November 29, 2011 |
| Last Updated: | November 30, 2011 |
| Health Authority: | Israel: Ministry of Health |
Additional relevant MeSH terms:
|
Back Injuries Osteoporosis Spinal Fractures Stress, Psychological Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Spinal Injuries Wounds and Injuries Fractures, Bone Behavioral Symptoms |
Analgesics Calcium Carbonate Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Antacids Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013