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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 7
- 主要终点
- Reduction of pain assessed by change in NRS from baseline to end of the trial
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Gastrolith
Gelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use.
干预措施: Gastrolith (Dietary Supplement)
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
干预措施: Placebo (Other)
结局指标
主要结局
Reduction of pain assessed by change in NRS from baseline to end of the trial
时间窗: from baseline to end of the trial
• Change from baseline to end-of-trial on NRS during movement (scale of 0 to 10) computed as follows. NRSchange = NRS42 - NRS0 NRS42 - NRS score at day 42 (end-of-trial) NRS0 - NRS score at day 0 (baseline)
次要结局
- Reduction of pain assessed by change in BPI from baseline to end-of-trial(baseline to end-of-trial)
- Reduction of disability assessed by change in ODI from baseline to end-of-trial(baseline to end-of-trial)
- Reduction of ASOC assessed by weekly change in analgesic consumption diaries from baseline to end of trial(baseline to end of trial)
- All adverse events and serious adverse events will be collected and reported(Baseline until four (4) weeks after completion of the study.)