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Clinical Trials Study Design
The safety and efficacy of SOMA® 250 mg were shown in two double-blind, randomized, placebo-controlled, multicenter trials with 1,300 patients.1
Study Patient Groups
Clinical trials in support of SOMA 250 mg included the following study groups:
- Study 1 compared SOMA 250 mg (n = 257) and SOMA® 350 mg (n = 264) to placebo (n = 263)
- Study 2 compared SOMA 250 mg (n = 267) to placebo (n = 277)
Drug Exclusions
Concomitant use of analgesics, other muscle relaxants, or sedative/hypnotics was prohibited.1
Study Methods
Patient populations for Study 1 and Study 2 had acute lower backache rated as moderate or severe within 3 days of treatment onset. Carisoprodol 250 mg tablets were given 3 times daily and at bedtime for 7 days.
Primary Endpoints
The primary endpoints for both studies were evaluated on day 3 and include:
- Patient-rated global impression of change*
- Relief from starting backache
Reference
(1) SOMA [package insert]. Somerset, NJ: Meda Healthcare Inc.; 2007.
*Global impression of change is an exercise that asked patients to compare how they felt before taking the study medication to how they felt after (regardless of whether or not they attributed change to the medication). Change was measure on a 5-point scale with 4 = marked improvement and 0 = worsening.
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Important Information
SOMA (carisoprodol) is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. SOMA should be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration.
Since the effects of SOMA and CNS depressants (including alcohol) or psychotropic drugs may be additive, appropriate caution should be exercised with patients who take more than one of these agents simultaneously. In postmarketing experience with SOMA, cases of dependence, withdrawal, and abuse have been reported with prolonged use. SOMA should be used with caution in addiction-prone patients. There have been postmarketing reports of seizures in SOMA treated patients with most cases having occurred in the setting of multiple drug overdoses.
Most common side effects include drowsiness, dizziness and headache.
Please see full Prescribing Information.
SOMA® 250 mg is distributed by Meda Pharmaceuticals.
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