Trial Outcomes & Findings for Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back (NCT NCT00671879)
NCT ID: NCT00671879
Last Updated: 2012-11-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
830 participants
Primary outcome timeframe
baseline to 14 days
Results posted on
2012-11-21
Participant Flow
Participant milestones
| Measure |
Carisprodol SR 700 mg
Carisoprodol 700 mg twice daily
|
Carisoprodol SR 500mg
Carisoprodol SR 500 mg twice daily
|
Placebo
Placebo treatment arm
|
|---|---|---|---|
|
Overall Study
STARTED
|
281
|
279
|
280
|
|
Overall Study
COMPLETED
|
281
|
275
|
274
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
6
|
Reasons for withdrawal
| Measure |
Carisprodol SR 700 mg
Carisoprodol 700 mg twice daily
|
Carisoprodol SR 500mg
Carisoprodol SR 500 mg twice daily
|
Placebo
Placebo treatment arm
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
6
|
Baseline Characteristics
Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
Baseline characteristics by cohort
| Measure |
Carisprodol SR 700 mg
n=281 Participants
Carisoprodol 700 mg twice daily
|
Carisoprodol SR 500mg
n=279 Participants
Carisoprodol SR 500 mg twice daily
|
Placebo
n=280 Participants
Placebo treatment arm
|
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
|
279 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
838 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age Continuous
|
41.5 years
STANDARD_DEVIATION 12.35 • n=5 Participants
|
41.6 years
STANDARD_DEVIATION 11.79 • n=7 Participants
|
41.4 years
STANDARD_DEVIATION 11.86 • n=5 Participants
|
41.5 years
STANDARD_DEVIATION 12.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
438 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
402 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
281 participants
n=5 Participants
|
279 participants
n=7 Participants
|
280 participants
n=5 Participants
|
840 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline to 14 daysPopulation: intent to treat(ITT) population least square mean(LSMEAN, LSMEAN) diff vs Placebo
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.
Outcome measures
| Measure |
Carisprodol SR 700 mg
n=270 Participants
Carisoprodol SR 700 mg twice daily
|
Carisoprodol SR 500mg
n=271 Participants
Carisoprodol SR 500 mg twice daily
|
Placebo
n=264 Participants
Placebo treatment arm
|
|---|---|---|---|
|
Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale
|
16.4 mm
Standard Deviation 1.30
|
15.5 mm
Standard Deviation 1.34
|
15.2 mm
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: baseline and day +14Population: Intent to Treat(ITT) population
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.
Outcome measures
| Measure |
Carisprodol SR 700 mg
n=135 Participants
Carisoprodol SR 700 mg twice daily
|
Carisoprodol SR 500mg
n=141 Participants
Carisoprodol SR 500 mg twice daily
|
Placebo
n=142 Participants
Placebo treatment arm
|
|---|---|---|---|
|
Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)
|
4.2 marked statements
Standard Error 0.64
|
5.0 marked statements
Standard Error 0.64
|
4.3 marked statements
Standard Error 0.65
|
Adverse Events
Carisprodol SR 700 mg
Serious events: 0 serious events
Other events: 98 other events
Deaths: 0 deaths
Carisoprodol SR 500mg
Serious events: 3 serious events
Other events: 94 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carisprodol SR 700 mg
n=281 participants at risk
Carisoprodol 700 mg twice daily
|
Carisoprodol SR 500mg
n=275 participants at risk
Carisoprodol SR 500 mg twice daily
|
Placebo
n=274 participants at risk
Placebo treatment arm
|
|---|---|---|---|
|
Infections and infestations
atypical pneumonitis
|
0.00%
0/281
|
0.36%
1/275 • Number of events 1
|
0.00%
0/274
|
|
Vascular disorders
stroke
|
0.00%
0/281
|
0.36%
1/275 • Number of events 1
|
0.00%
0/274
|
|
Infections and infestations
severe influenza
|
0.00%
0/281
|
0.36%
1/275 • Number of events 1
|
0.00%
0/274
|
Other adverse events
| Measure |
Carisprodol SR 700 mg
n=281 participants at risk
Carisoprodol 700 mg twice daily
|
Carisoprodol SR 500mg
n=275 participants at risk
Carisoprodol SR 500 mg twice daily
|
Placebo
n=274 participants at risk
Placebo treatment arm
|
|---|---|---|---|
|
Nervous system disorders
somnolence
|
9.6%
27/281 • Number of events 27
|
13.8%
38/275 • Number of events 38
|
7.3%
20/274 • Number of events 20
|
|
Nervous system disorders
headache
|
4.3%
12/281 • Number of events 12
|
4.7%
13/275 • Number of events 13
|
3.6%
10/274 • Number of events 10
|
|
Nervous system disorders
dizziness
|
3.9%
11/281 • Number of events 11
|
4.0%
11/275 • Number of events 11
|
1.5%
4/274 • Number of events 4
|
|
Gastrointestinal disorders
nausea
|
5.0%
14/281 • Number of events 14
|
2.5%
7/275 • Number of events 7
|
0.36%
1/274 • Number of events 1
|
|
General disorders
fatigue
|
1.4%
4/281 • Number of events 4
|
2.2%
6/275 • Number of events 6
|
0.73%
2/274 • Number of events 2
|
|
Blood and lymphatic system disorders
increased blood CPK
|
1.4%
4/281 • Number of events 4
|
1.1%
3/275 • Number of events 3
|
1.5%
4/274 • Number of events 4
|
|
Nervous system disorders
insomnia
|
1.1%
3/281 • Number of events 3
|
1.1%
3/275 • Number of events 3
|
1.1%
3/274 • Number of events 3
|
|
Gastrointestinal disorders
constipation
|
1.1%
3/281 • Number of events 3
|
0.73%
2/275 • Number of events 2
|
0.73%
2/274 • Number of events 2
|
|
Gastrointestinal disorders
diarrhea
|
1.1%
3/281 • Number of events 3
|
0.73%
2/275 • Number of events 2
|
0.36%
1/274 • Number of events 1
|
|
General disorders
dry mouth
|
0.36%
1/281 • Number of events 1
|
1.5%
4/275 • Number of events 4
|
0.00%
0/274
|
|
Gastrointestinal disorders
vomiting
|
1.4%
4/281 • Number of events 4
|
0.36%
1/275 • Number of events 1
|
0.00%
0/274
|
|
Nervous system disorders
Lasegues Test Positive
|
0.71%
2/281 • Number of events 2
|
1.1%
3/275 • Number of events 3
|
0.00%
0/274
|
|
Psychiatric disorders
anxiety
|
1.1%
3/281 • Number of events 3
|
0.36%
1/275 • Number of events 1
|
0.36%
1/274 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
clumsiness
|
1.4%
4/281 • Number of events 4
|
0.00%
0/275
|
0.00%
0/274
|
|
Nervous system disorders
pain in extremity
|
1.1%
3/281 • Number of events 3
|
0.00%
0/275
|
0.36%
1/274 • Number of events 1
|
Additional Information
David Ginsberg, DO Sr Dir Medical Scientific Affairs
Meda Pharma US
Phone: 732 564 2347
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place