Lower Back Pain
Conditions
Brief summary
The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.
Detailed description
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.
Interventions
DRUGCarisoprodol SR
700 mg twice daily
DRUGPlacebo
Placebo tablet
Sponsors
Meda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Rating of Pain on a 100-point Visual Analog Scale (VAS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) | up to 14 days | — |
| Adverse Event Assessment | up to 21 days | the number of adverse events reported during the course of the study as reported by the participants |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carisoprodol 700mg tablet experimental formulation | 281 |
| Carisoprodol 500mg Tablet tablet experimental formulation | 280 |
| Placebo Tablet tablet placebo no experimental formulation | 279 |
| Total | 840 |
Baseline characteristics
| Characteristic | Carisoprodol 500mg Tablet | Placebo Tablet | Carisoprodol 700mg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 3 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 278 Participants | 275 Participants | 278 Participants | 831 Participants |
| Age Continuous | 41.4 years STANDARD_DEVIATION 12.6 | 40.9 years STANDARD_DEVIATION 12.72 | 40.3 years STANDARD_DEVIATION 13.05 | 40.9 years STANDARD_DEVIATION 12.78 |
| Region of Enrollment United States | 280 participants | 279 participants | 281 participants | 840 participants |
| Sex: Female, Male Female | 144 Participants | 136 Participants | 133 Participants | 413 Participants |
| Sex: Female, Male Male | 136 Participants | 143 Participants | 148 Participants | 427 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 78 / 278 | 65 / 280 | 37 / 275 |
| serious Total, serious adverse events | 0 / 278 | 1 / 280 | 0 / 275 |
Outcome results
Primary
Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)
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
Time frame: up to 14 days
Population: efficacy analyses based on ITT population. LOCF used to impute missing data. To detect a 14% difference between the carisoprodol and placebo treated subjects, 196 ITTsubjects per group (alpha level 0.025,power 80%).Assuming 15% dropout rate, 226 subjects per group were needed.A total of678 subjects were required to achieve 584 ITT subjects.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Carisoprodol 500mg Tablets | Subject Rating of Pain on a 100-point Visual Analog Scale (VAS) | 27.5 mm |
| Carisoprodol 700mg Tablets | Subject Rating of Pain on a 100-point Visual Analog Scale (VAS) | 28 mm |
| Placebo Tablets | Subject Rating of Pain on a 100-point Visual Analog Scale (VAS) | 28.6 mm |
Secondary
Adverse Event Assessment
the number of adverse events reported during the course of the study as reported by the participants
Time frame: up to 21 days
Secondary
Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)
Time frame: up to 14 days