NCT01482858

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Amorphical Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. The 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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-07-01
• Completion: 2012-08-01
• First posted: 2011-12-01
• Last updated: 2024-02-28

Locations

5 sites across 1 country: Israel