search
Back to results

A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Tandrilax
Dolamin Flex
Sponsored by
Farmoquimica S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Clonixin, Anti-Inflammatory Agents, Non-Steroidal, Cyclooxygenase Inhibitors, Lysine, L-Lysine, Lysine Acetate, Lysine Hydrochloride, Amitriptyline

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed of the nature of the study and given written informed consent
  • Patients with mild to moderate lumbago
  • Aged between 18 and 65 years old

Exclusion Criteria:

  • Known allergy or sensitivity to drug components
  • Treatment with another anti inflammatory or corticoid
  • Treatment with oral anticoagulants
  • Treatment with oxidase monoamine 2 weeks before the study
  • Treatment with methotrexate
  • Stomach or duodenal ulcer and gastritis
  • Dehydration
  • Acute myocardial infarction or heart failure
  • Hyperthyroidism
  • Pregnant or lactating patients
  • Treatment with lithium
  • User of alcohol and barbiturates
  • Hepatic or renal failure

Sites / Locations

  • Hospital São Luiz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Tandrilax

Dolamin Flex

Arm Description

Reference product Intervention: Drug: Tandrilax (caffeine+carisoprodol+sodium diclofenac+paracetamol)

Test product Intervention: Drug: Dolamin Flex (Lysine clonixinate and cyclobenzaprine)

Outcomes

Primary Outcome Measures

Pain average reduction
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.

Secondary Outcome Measures

Identification of possible gastrointestinal effects
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.

Full Information

First Posted
August 18, 2011
Last Updated
March 7, 2012
Sponsor
Farmoquimica S.A.
Collaborators
Pharmagenix Projetos em Medicina Farmacêutica Ltda.
search

1. Study Identification

Unique Protocol Identification Number
NCT01421433
Brief Title
A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Farmoquimica S.A.
Collaborators
Pharmagenix Projetos em Medicina Farmacêutica Ltda.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Clonixin, Anti-Inflammatory Agents, Non-Steroidal, Cyclooxygenase Inhibitors, Lysine, L-Lysine, Lysine Acetate, Lysine Hydrochloride, Amitriptyline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tandrilax
Arm Type
Active Comparator
Arm Description
Reference product Intervention: Drug: Tandrilax (caffeine+carisoprodol+sodium diclofenac+paracetamol)
Arm Title
Dolamin Flex
Arm Type
Experimental
Arm Description
Test product Intervention: Drug: Dolamin Flex (Lysine clonixinate and cyclobenzaprine)
Intervention Type
Drug
Intervention Name(s)
Tandrilax
Intervention Description
Tandrilax (caffeine, carisoprodol, sodium diclofenac, paracetamol). Tablets, administered 3 times a day, for 7 consecutive days.
Intervention Type
Drug
Intervention Name(s)
Dolamin Flex
Intervention Description
Dolamin Flex (lysine clonixinate and cyclobenzaprine). Tablets, administered 3 times a day, for 7 consecutive days.
Primary Outcome Measure Information:
Title
Pain average reduction
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Identification of possible gastrointestinal effects
Description
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.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed of the nature of the study and given written informed consent Patients with mild to moderate lumbago Aged between 18 and 65 years old Exclusion Criteria: Known allergy or sensitivity to drug components Treatment with another anti inflammatory or corticoid Treatment with oral anticoagulants Treatment with oxidase monoamine 2 weeks before the study Treatment with methotrexate Stomach or duodenal ulcer and gastritis Dehydration Acute myocardial infarction or heart failure Hyperthyroidism Pregnant or lactating patients Treatment with lithium User of alcohol and barbiturates Hepatic or renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rogerio T. Silva, Phd
Organizational Affiliation
Hospital São Luiz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital São Luiz
City
São Paulo
ZIP/Postal Code
05673-050
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rogerio T. Silva
Phone
551181716767
Email
rogerio@neo.org.br

12. IPD Sharing Statement

Learn more about this trial

A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol

We'll reach out to this number within 24 hrs