Trial · NCT00671502

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

NCT00671502, Phase 3, Completed, Meda Pharmaceuticals; results first posted 2011-11-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back. Trials, record NCT00671502. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00671502

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back
NCT number: NCT00671502
Status: Completed
Phases: Phase 3
Enrollment: 840 participants, actual
Lead sponsor: Meda Pharmaceuticals
Conditions: Lower Back Pain
Interventions: Carisoprodol SR, Carisoprodol SR, Placebo
First posted: 2008-05-05
Last updated: 2011-11-09
Results first posted: 2011-11-09

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)	up to 14 days
Secondary	Adverse Event Assessment	up to 21 days	the number of adverse events reported during the course of the study as reported by the participants

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)	up to 14 days	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.	mm	LEAST_SQUARES_MEAN
SECONDARY	Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)	up to 14 days
SECONDARY	Adverse Event Assessment	up to 21 days		participants	NUMBER

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)	Carisoprodol 500mg Tablets	27.5	95% Confidence Interval -21 to 83	mm
Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)	Carisoprodol 700mg Tablets	28	95% Confidence Interval -19 to 89	mm
Subject Rating of Pain on a 100-point Visual Analog Scale (VAS)	Placebo Tablets	28.6	95% Confidence Interval -36 to 82	mm

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Carisoprodol 700mg	281
Overall Study	STARTED	Carisoprodol 500mg Tablet	280
Overall Study	STARTED	Placebo Tablet	279
Overall Study	COMPLETED	Carisoprodol 700mg	242
Overall Study	COMPLETED	Carisoprodol 500mg Tablet	241
Overall Study	COMPLETED	Placebo Tablet	252
Overall Study	NOT COMPLETED	Carisoprodol 700mg	39
Overall Study	NOT COMPLETED	Carisoprodol 500mg Tablet	39
Overall Study	NOT COMPLETED	Placebo Tablet	27

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	somnolence	Nervous system disorders	Carisoprodol 700mg	44	44	44
other	somnolence	Nervous system disorders	Carisoprodol 500mg Tablet	36	280	36
other	somnolence	Nervous system disorders	Placebo Tablet	18	275	18
other	dizziness	Nervous system disorders	Carisoprodol 700mg	23	278	23
other	dizziness	Nervous system disorders	Carisoprodol 500mg Tablet	12	280	12
other	dizziness	Nervous system disorders	Placebo Tablet	6	275	6
other	nausea	Gastrointestinal disorders	Carisoprodol 700mg	5	278	5
other	nausea	Gastrointestinal disorders	Carisoprodol 500mg Tablet	12	280	12
other	nausea	Gastrointestinal disorders	Placebo Tablet	6	275	6
other	fatigue	General disorders	Carisoprodol 700mg	5	278	5

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Carisoprodol 700mg
Total, all-cause mortality	Carisoprodol 500mg Tablet
Total, all-cause mortality	Placebo Tablet
Total, other adverse events	Carisoprodol 700mg	78	278
Total, other adverse events	Carisoprodol 500mg Tablet	65	280
Total, other adverse events	Placebo Tablet	37	275
Total, serious adverse events	Carisoprodol 700mg	0	278
Total, serious adverse events	Carisoprodol 500mg Tablet	1	280
Total, serious adverse events	Placebo Tablet	0	275

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00671502

GET https://conductscience.org/api/trials/v1/NCT00671502/registered

API reference For AI assistants