Trial record 6 of 16 for:    Open Studies | "Back Injuries"

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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014