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 will be 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 consists of a baseline screening (Study Day 1), during which subjects will be evaluated for inclusion/exclusion criteria, and a 7-day double-blind treatment period (Study Day 1 through Study Day 7). Subjects will be randomly assigned to be dosed twice daily with one of the following double-blind treatments: SR carisoprodol 500-mg tablets, SR carisoprodol 700-mg tablets, or placebo. Subjects will be evaluated in the clinic on Study Days 1, 3 and 7. Subjects who remain symptomatic on Study Day 7 will be allowed to continue in the study for a 7-day, double-blind extension period at the discretion of the Investigator. Subjects will be contacted by telephone for a safety follow-up 7 days after the last dose of study medication. A pharmacokinetic (PK) substudy will be conducted at selected sites. These sites will obtain 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
700 mg twice daily tablet
DRUGCarisoprodol SR 500 mg
carisoprodol SR 500 mg tablet
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 VAS * Ability to discontinue all analgesics, 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 nucleus pulpous, spondylolisthesis, spinal stenosis * Presence of underlying chronic back pain * Neurological signs and symptoms such as numbness, tingling, foot drop, paresthesia, unexplained constipation, urinary retention or urinary incontinence * Myocardial infarction 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 vertebral fracture * Underlying rheumatologic disease such as rheumatoid arthritis, ankylosing spondylitis, etc. * Presence of active influenza or other viral syndromes * Morbid obesity (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 hyperreflexic 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 Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale | baseline to 14 days | on a visual analog scale of 0 to 100 millimeters(mm) with 0 being no pain and 100 being maximum pain By measuring the amount of pain before and during treatment done at each visit and recording the difference in mm.During treatment scores were averaged and this average was compared to the baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) | baseline and day +14 | Subject functional assessment based on the Roland-Morris Disability Questionnaire (RMDQ)at day 14.Subjects were asked to read a list of 24 sentences that people have used to describe themselves when they had back pain, and were asked to mark those statements that described their condition that day. The number of marked statements was added. A decrease in the number of marked statements from baseline represented improvement on the RMDQ. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carisprodol SR 700 mg Carisoprodol 700 mg twice daily | 281 |
| Carisoprodol SR 500mg Carisoprodol SR 500 mg twice daily | 279 |
| Placebo Placebo treatment arm | 280 |
| Total | 840 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 4 | 6 |
Baseline characteristics
| Characteristic | Carisoprodol SR 500mg | Placebo | Carisprodol SR 700 mg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 279 Participants | 280 Participants | 279 Participants | 838 Participants |
| Age Continuous | 41.6 years STANDARD_DEVIATION 11.79 | 41.4 years STANDARD_DEVIATION 11.86 | 41.5 years STANDARD_DEVIATION 12.35 | 41.5 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 279 participants | 280 participants | 281 participants | 840 participants |
| Sex: Female, Male Female | 145 Participants | 144 Participants | 149 Participants | 438 Participants |
| Sex: Female, Male Male | 134 Participants | 136 Participants | 132 Participants | 402 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 | 98 / 281 | 94 / 275 | 49 / 274 |
| serious Total, serious adverse events | 0 / 281 | 3 / 275 | 0 / 274 |
Outcome results
Primary
Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale
on a visual analog scale of 0 to 100 millimeters(mm) with 0 being no pain and 100 being maximum pain By measuring the amount of pain before and during treatment done at each visit and recording the difference in mm.During treatment scores were averaged and this average was compared to the baseline value.
Time frame: baseline to 14 days
Population: intent to treat(ITT) population least square mean(LSMEAN, LSMEAN) diff vs Placebo
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Carisprodol SR 700 mg | Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale | 16.4 mm | Standard Deviation 1.3 |
| Carisoprodol SR 500mg | Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale | 15.5 mm | Standard Deviation 1.34 |
| Placebo | Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale | 15.2 mm | Standard Deviation 1.32 |
Secondary
Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)
Subject functional assessment based on the Roland-Morris Disability Questionnaire (RMDQ)at day 14.Subjects were asked to read a list of 24 sentences that people have used to describe themselves when they had back pain, and were asked to mark those statements that described their condition that day. The number of marked statements was added. A decrease in the number of marked statements from baseline represented improvement on the RMDQ.
Time frame: baseline and day +14
Population: Intent to Treat(ITT) population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Carisprodol SR 700 mg | Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) | 4.2 marked statements | Standard Error 0.64 |
| Carisoprodol SR 500mg | Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) | 5.0 marked statements | Standard Error 0.64 |
| Placebo | Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) | 4.3 marked statements | Standard Error 0.65 |