Analgesic Effects of the Gastrolith, in Osteoporotic Patients Suffering From Recent Skeletal Pain Caused by Vertebral Fractures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Amorphical Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
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

November 29, 2011
November 30, 2011
December 2011
July 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01482858 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Analgesic Effects of the Gastrolith, in Osteoporotic Patients Suffering From Recent Skeletal Pain Caused by Vertebral Fractures
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Osteoporosis
  • Dietary Supplement: Gastrolith
    Gelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use.
  • 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
  • Experimental: Gastrolith
    Gelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use.
    Intervention: Dietary Supplement: Gastrolith
  • 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
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
August 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Galit Shaltiel-Glod, PhD 972 (0)8-6479411- galits@amorphical.com
Israel
 
NCT01482858
AMCS-003
No
Amorphical Ltd.
Amorphical Ltd.
Not Provided
Principal Investigator: Eliad Davidson, MD Hadassah Ein Carem Medical Center, Jerusalem, Israel
Amorphical Ltd.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP