Trial Outcomes & Findings for A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back (NCT NCT00671502)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

840 participants

Primary outcome timeframe

up to 14 days

Results posted on

2011-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	Carisoprodol 700mg tablet experimental formulation	Carisoprodol 500mg Tablet tablet experimental formulation	Placebo Tablet tablet placebo no experimental formulation
Overall Study STARTED	281	280	279
Overall Study COMPLETED	242	241	252
Overall Study NOT COMPLETED	39	39	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carisoprodol 700mg n=281 Participants tablet experimental formulation	Carisoprodol 500mg Tablet n=280 Participants tablet experimental formulation	Placebo Tablet n=279 Participants tablet placebo no experimental formulation	Total n=840 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	278 Participants n=5 Participants	278 Participants n=7 Participants	275 Participants n=5 Participants	831 Participants n=4 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Age Continuous	40.3 years STANDARD_DEVIATION 13.05 • n=5 Participants	41.4 years STANDARD_DEVIATION 12.6 • n=7 Participants	40.9 years STANDARD_DEVIATION 12.72 • n=5 Participants	40.9 years STANDARD_DEVIATION 12.78 • n=4 Participants
Sex: Female, Male Female	133 Participants n=5 Participants	144 Participants n=7 Participants	136 Participants n=5 Participants	413 Participants n=4 Participants
Sex: Female, Male Male	148 Participants n=5 Participants	136 Participants n=7 Participants	143 Participants n=5 Participants	427 Participants n=4 Participants
Region of Enrollment United States	281 participants n=5 Participants	280 participants n=7 Participants	279 participants n=5 Participants	840 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Carisoprodol 500mg Tablets n=280 Participants carisoprodol 500mg tablets treatment arm	Carisoprodol 700mg Tablets n=281 Participants carisoprodol 700mg tablets treatment arm	Placebo Tablets n=279 Participants placebo tablets treatment arm
Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)	27.5 mm Interval -21.0 to 83.0	28 mm Interval -19.0 to 89.0	28.6 mm Interval -36.0 to 82.0

SECONDARY outcome

Timeframe: up to 14 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 21 days

the number of adverse events reported during the course of the study as reported by the participants

Outcome measures

Outcome data not reported

Adverse Events

Carisoprodol 700mg

Serious events: 0 serious events

Other events: 78 other events

Deaths: 0 deaths

Carisoprodol 500mg Tablet

Serious events: 1 serious events

Other events: 65 other events

Deaths: 0 deaths

Placebo Tablet

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Carisoprodol 700mg n=278 participants at risk tablet experimental formulation	Carisoprodol 500mg Tablet n=280 participants at risk tablet experimental formulation	Placebo Tablet n=275 participants at risk tablet placebo no experimental formulation
Cardiac disorders transient ischemic attack	0.00% 0/278 • up to 21 days	0.36% 1/280 • Number of events 1 • up to 21 days	0.00% 0/275 • up to 21 days

Other adverse events

Other adverse events
Measure	Carisoprodol 700mg n=278 participants at risk tablet experimental formulation	Carisoprodol 500mg Tablet n=280 participants at risk tablet experimental formulation	Placebo Tablet n=275 participants at risk tablet placebo no experimental formulation
Nervous system disorders somnolence	100.0% 44/44 • Number of events 44 • up to 21 days	12.9% 36/280 • Number of events 36 • up to 21 days	6.5% 18/275 • Number of events 18 • up to 21 days
Nervous system disorders dizziness	8.3% 23/278 • Number of events 23 • up to 21 days	4.3% 12/280 • Number of events 12 • up to 21 days	2.2% 6/275 • Number of events 6 • up to 21 days
Gastrointestinal disorders nausea	1.8% 5/278 • Number of events 5 • up to 21 days	4.3% 12/280 • Number of events 12 • up to 21 days	2.2% 6/275 • Number of events 6 • up to 21 days
General disorders fatigue	1.8% 5/278 • Number of events 5 • up to 21 days	1.8% 5/280 • Number of events 5 • up to 21 days	0.73% 2/275 • Number of events 2 • up to 21 days
General disorders headache	2.9% 8/278 • Number of events 8 • up to 21 days	1.4% 4/280 • Number of events 4 • up to 21 days	1.8% 5/275 • Number of events 5 • up to 21 days

Additional Information

David Ginsberg, MD Sr Medical Director

Meda Pharma US

Phone: 732 564 2364

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place