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

This study has been completed.

Study NCT00671502 Information provided by Meda Pharmaceuticals

First Received on May 1, 2008. Last Updated on October 4, 2011 History of Changes

Results First Received: June 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Lower Back Pain
Interventions:	Drug: Carisoprodol SR Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Carisoprodol 700mg	tablet experimental formulation
Carisoprodol 500mg Tablet	tablet experimental formulation
Placebo Tablet	tablet placebo no experimental formulation

Participant Flow: Overall Study

	Carisoprodol 700mg	Carisoprodol 500mg Tablet	Placebo Tablet
STARTED	281	280	279
COMPLETED	242	241	252
NOT COMPLETED	39	39	27

Baseline Characteristics

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Reporting Groups

	Description
Carisoprodol 700mg	tablet experimental formulation
Carisoprodol 500mg Tablet	tablet experimental formulation
Placebo Tablet	tablet placebo no experimental formulation

Baseline Measures

	Carisoprodol 700mg	Carisoprodol 500mg Tablet	Placebo Tablet	Total
Number of Participants [units: participants]	281	280	279	840
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	278	278	275	831
>=65 years	3	2	4	9
Age [units: years] Mean ± Standard Deviation	40.3 ± 13.05	41.4 ± 12.6	40.9 ± 12.72	40.9 ± 12.78
Gender [units: participants]
Female	133	144	136	413
Male	148	136	143	427
Region of Enrollment [units: participants]
United States	281	280	279	840

Outcome Measures

1. Primary:

Subject Rating of Pain on a 100-point Visual Analog Scale (VAS) [ Time Frame: up to 14 days ]

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2. Secondary:

Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: up to 14 days ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Adverse Event Assessment [ Time Frame: up to 21 days ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: David Ginsberg, MD Sr Medical Director
Organization: Meda Pharma US
phone: 732 564 2364
e-mail: david.ginsberg@meda.us

No publications provided

Responsible Party:	Meda Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00671502 History of Changes
Other Study ID Numbers:	MP510
Study First Received:	May 1, 2008
Results First Received:	June 28, 2011
Last Updated:	October 4, 2011
Health Authority:	United States: Food and Drug Administration