Trial record 3 of 9 for:
CARISOPRODOL
A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol
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ClinicalTrials.gov Identifier: NCT01421433 |
Recruitment Status : Unknown
Verified March 2012 by Farmoquimica S.A..
Recruitment status was: Not yet recruiting
First Posted : August 22, 2011
Last Update Posted : March 8, 2012
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Sponsor:
Farmoquimica S.A.
Collaborator:
Pharmagenix Projetos em Medicina Farmacêutica Ltda.
Information provided by (Responsible Party):
Farmoquimica S.A.
Tracking Information | ||||
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First Submitted Date ICMJE | August 18, 2011 | |||
First Posted Date ICMJE | August 22, 2011 | |||
Last Update Posted Date | March 8, 2012 | |||
Study Start Date ICMJE | May 2012 | |||
Estimated Primary Completion Date | August 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Pain average reduction [ Time Frame: 7 days ] The metric that will be used is Pain Analog Visual Scale (PAVS), that it is a graphical representation with values 0-10.
To use the PAVS, the principal investigator should question the patient regarding their pain level, and the value 0 (zero) means no pain and the value 10 (ten) indicates the maximum pain level.
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Original Primary Outcome Measures ICMJE |
Pain average reduction [ Time Frame: 7 days ] The metric that will be used is Pain Analog Visual Scale.
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
Identification of possible gastrointestinal effects [ Time Frame: 7 days ] The metric that will be used is checking the safety data reported by the patient in the Patient Diary and / or using data reported by patients by Phone Call.
A diary will be given for the patient, to make notes about possible gastrointestinal adverse events.
The principal investigator should call to the patient to know about possible gastrointestinal adverse effects of the drug.
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Original Secondary Outcome Measures ICMJE |
Identification of possible gastrointestinal effects [ Time Frame: 7 days ] The metric that will be used is checking the safety data reported by the patient in the Patient Diary and / or using data reported by patients by Phone Call.
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol | |||
Official Title ICMJE | Non Inferiority,Phase III,Multicentric,Double Blind,Randomized,Parallel Study,Comparing Dolamin Flex (Lysine Clonixinate+Cyclobenzaprine) and Tandrilax(Caffeine +Carisoprodol+Diclofenac+Paracetamol)in Pain Reduction in Patients With Lumbago | |||
Brief Summary | Non inferiority, multicentric, double blind study whose the primary objective is to compare the effectiveness of two products in pain reduction. Primary endpoint: reduction in pain average at day 7 compared to day 1(baseline), using Analogue Visual Scale (AVS) for pain evaluation. Secondary endpoint: to evaluate the products safety at the gastrointestinal system. | |||
Detailed Description | Phase IIIb, non-inferiority, multicentric, double-blind study.Population: 160 patients, 80 in each study arm, both gender with mild to moderate lumbago, without irradiation and with muscle contraction, aged 18 (eighteen) and 65 (sixty five) years, without previous history of stomach or duodenal ulcer and gastritis. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Low Back Pain | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
160 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | January 2013 | |||
Estimated Primary Completion Date | August 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Brazil | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01421433 | |||
Other Study ID Numbers ICMJE | FQM 01/11 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Farmoquimica S.A. | |||
Study Sponsor ICMJE | Farmoquimica S.A. | |||
Collaborators ICMJE | Pharmagenix Projetos em Medicina Farmacêutica Ltda. | |||
Investigators ICMJE |
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PRS Account | Farmoquimica S.A. | |||
Verification Date | March 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |