Randomized, Double-Blind, Double-Dummy Trial of Two Sustained Release Formulations of Carisoprodol Compared to Placebo in Subjects With Acute, Painful, Musculoskeletal Spasm of the Lower Back
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 840
- 试验地点
- 68
- 主要终点
- Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.
详细描述
Methodology:
This was a randomized, double-blind, double-dummy, placebo-controlled, parallel-group study in subjects 18-70 years of age with acute, painful, muscle spasm of the lower back. The study consisted of a baseline screening (Study Day 1), during which subjects were evaluated for inclusion/exclusion criteria, and a 7-day double-blind treatment period (Study Day 1 through Study Day 7). Subjects were randomly assigned to be dosed twice daily with one of the following double-blind treatments: sustained release(SR) carisoprodol 500-mg tablets,sustained release (SR) carisoprodol 700-mg tablets, or placebo.
Subjects were evaluated in the clinic on Study Days 1, 3 and 7. Subjects who remained symptomatic on Study Day 7 were allowed to continue in the study for a 7-day, double-blind extension period at the discretion of the Investigator. Subjects were contacted by telephone for a safety follow-up 7 days after the last dose of study medication.
A pharmacokinetic (PK) substudy was conducted at selected sites. These sites obtained blood samples for PK analysis at the end of the 7-day treatment period and the 14-day treatment period, if applicable.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Onset of pain is within 3 days of first visit
- •Subject rating of pain must be 40 mm or greater on visual analog scale( VAS)
- •Ability to discontinue all analgesics, non steroidal anti inflammatory drug (NSAIDs), and other muscle relaxants
- •Willingness to provide written informed consent
- •Must be in generally good health
排除标准
- •Presence of sciatic pain
- •History of clinically significant spine pathology such as herniated nucleas pulposis, spondylolisthesis, spinal stenosis
- •Presence of underlying chronic back pain
- •Neurological signs and symptoms such as numbness, tingling, foot drop, parethesia, unexplained constipation, urinary retention or urinary incontinence
- •Myocardial infaction within one year of study
- •Cancer not in remission or in remission less than one year
- •HIV or other immunodeficiency syndromes
- •History of osteoporosis or at high risk for vetebral fracture
- •Underlying rheumatologic disease such as rheumatoid arthritis, ankylosing spondylitis, etc.
- •Presence of active influenze or other viral syndromes
- •Morbid obesity basal metabolic index(BMI >39)
- •Evidence of infection, such as low grade fever or neutrophilia
- •Existence of any medical/surgical condition that could interfere with the evaluation of the study medication
- •Known history of alcohol or drug abuse
- •Injury involving high potential for litigation, including worker's compensation or automobile accidents
- •Pregnancy or breast feeding
- •Women of child-bearing potential not abstinent or not practicing a medically acceptable method of contraception
- •Vertebral body or spinous process, percussive tenderness on physical exam
- •Any abnormalities in the following tests of both lower extremities: ankle dorsiflexion strength, great toe dorsiflexion strength, absent or hypereflexic Achilles or patellar tendor reflexes, abnormal sensory exam in the medial, dorsal or lateral aspect of the foot and positive straight leg raise test
- •Urgent medical conditions on comprehensive exam that might indicate a more serious condition should be treated urgently
研究组 & 干预措施
Carisoprodol 700mg
tablet sustained release (SR)
干预措施: Carisoprodol SR (Drug)
Carisoprodol 500mg
sustained release(SR) tablet
干预措施: Carisoprodol SR (Drug)
Placebo
tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)
时间窗: up to 14 days
the scale used was from 0 to 100 mm. 0 equaled no pain and 100 equaled maximum pain.participants measure their pain before treatment and during treatment at each visit
次要结局
- Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)(up to 14 days)
- Adverse Event Assessment(up to 21 days)