CONTROLLED, DOUBLE-BLIND, RANDOMIZED, MULTICENTER, FASE IIIb TRIAL DESIGNED TO EVALUATE THE EFFICACY AND TOLERABILITY OF THE FIXED COMBINATION OF THIOCOLCHICOSIDE PLUS DICLOFENAC POTASSIUM IN ACUTE PAINFUL MUSCLE CONTRACTURE

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

STUDY OF CLINICAL DOCUMENTATION, CONTROLLED, DOUBLE-BLIND, RANDOMIZED, MULTICENTER, DESIGNED TO EVALUATE THE EFFECTIVENESS AND TOLERANCE OF FIXED COMBINATION OF THIOCOLCHICOSIDE PLUS DICLOFENAC POTASSIUM IN REDUCTION OF ACUTE PAINFUL MUSCLE CONTRACTURE

Secondary indentifying numbers:

ECU-CONP-01

Issuing authority of the secondary identifying numbers:

Gutis Ltda. San Jose, Costa Rica

Source(s) of monetary or material support:

Gutis Ltda. San Jose, Costa Rica

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Dr. Ivan Guayasamín, Medical Surgeon

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Ecuador

Research ethics committees:

Bioethics Committee of the Central University of Ecuador, Biomedical Center. Date of approval: 29/03/2012 Reference number: MK0869-208. Centralized Committee for the study

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

15/04/2012

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Acute painful striated muscle contracture,(cervical pain, backache, low back pain without sciatica, etc.)

Intervention(s):

Group I (experimental): 1 single tablet that contains in combination thiocolchicoside 4mg plus potassium diclofenac 50 mg every 12 hours by mouth to complete 10 doses, 5 days of treatment (TIO+DICLOK). Group II (Control): placebo, 1 tablet inactive every 12 hours orally to complete 10 doses, 5 days of treatment. Group I and Group II: Acetaminophen 500 mg as rescue medication PRN

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1. Evaluation of efficacy 1.1 Muscular contracture degree by a visual inspection (Contracture visible muscle mass with fixed-antalgic attitude, Contracture visible muscle mass without fixed-antalgic attitude, No visual signs of muscle contracture). Measuring time: at baseline and after finished the treatment (Day 5). 1.2 Muscular contracture degree by palpation (Contracture severe with evoked pain during palpation, Contracture moderate with evoked pain during palpation, Contracture mild without evoked pain during palpation, Absence contracture). Measuring time: at baseline and after finished the treatment (Day 5). 1.3 Degree of overall pain intensity (Visual Analogue Scale (VAS) of 10 cm, ranging from no pain to worst pain imaginable very severe). Measuring time: at baseline and after finished the treatment (Day 5). 2. Evaluation of tolerability 2.1 Possible Adverse Reactions (AR). Measuring time: after finished the treatment (Day 5): - Occurrence of some AR in the subject (yes / no) - Nature of the AR (adverse event name) - Intensity of AR (Mild, moderate, severe) - Duration of AR (difference between the start date and the completion of the event) - Causation (causal categories described by the Uppsala Monitoring Centre (WHO): Definite, probable, possible, unlikely, conditional, not evaluable) - Treatment (medication withdrawal, other) - Severity of AR (Severe / serious; Not severe / not serious)

Key secondary outcomes:

1. Efficacy 1.1 Efficacy of treatment by the patient (Very effective, Effective, Moderately Effective, Not effective (Ineffective). Measuring time: at the end of the treatment (Day 5) 1.2 Rescue medication (yes / no). Measuring time: at the end of the treatment (Day 5) 1.3 Total Tablets of rescue medication (Number of tablets). Measuring time: at the end of the treatment (Day 5) 1.4 Daily Tablets of rescue medication (Number of tablets). Measuring time: daily during the treatment 2. Tolerability 2.1 Tolerability of treatment by the patient (Very good, Good, Fair, Poor). Measuring time: at the end of the treatment (Day 5) 2.2 Degree of alertness - sleepiness (Visual Analogue Scale (VAS) of 10 cm, ranging from awake (alert) to severe sleepiness (sleeping)). Measuring time: at baseline and after finished the treatment (Day 5) 2.3 Psychomotor activity level (Tapping test (hitting the keyboard of a personal computer as soon as possible) for 30 seconds, record the number of hits). Measuring time: at baseline and after finished the treatment (Day 5) 2.4 Psychomotor activity level (Pauli Test for 3 minutes, recorded the number of successes achieved). Measuring time: at baseline and after finished the treatment (Day 5) 3. Efficacy and Tolerability 3.1 Overall rating of treatment by the investigator (Clinical Global Impression scale). Measuring time: at the end of the treatment (Day 5) 3.2 Overall treatment satisfaction by the investigator (Very Satisfied, Satisfied, Moderately satisfied, not satisfied (dissatisfied)). Measuring time: at the end of the treatment (Day 5) 3.3 Overall treatment satisfaction by the patient (Very Satisfied, Satisfied, Moderately satisfied, not satisfied (dissatisfied)). Measuring time: at the end of the treatment (Day 5)

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

59 years

Inclusion criteria:

1. Ambulatory subjects suffering from acute muscle spasm recent (= 72 hours), with visible striated muscle spasm, with or without fixed-antalgic attitude (Rating on a scale of visual assessment of muscle contracture of 2 or 3) secondary to conditions such as neck pain, backache, low back pain, etc. and / or 2. Subjects showing an intensity of at least moderate pain, showing a minimum in the visual analog scale (VAS) ? to 4 cm. 3. Subjects over 18 years and under 60 years of age. 4. Subjects with good health, confirmed by: a. Medical history and prior medication, and b. Baseline physical examination, including vital signs 5. Subjects able to take oral medication. 6. Subjects who agree to, and shall be able to: a. Read and understand written instructions, and b. Complete the Patient's Journal. 7. Subjects after a full explanation of the study, understand the nature of it and agree to sign informed consent to participate in it. 8. The first patients, according to the number assigned to each researcher, who meet the above requirements within the time of recruitment.

Exclusion criteria:

1. Subjects younger than 18 or older than 60 years and in general subjects not meeting inclusion criteria 2. Subjects in whom treatment with thiocolchicoside and / or diclofenac potassium has previously failed. 3. Subjects who have discontinued treatment with thiocolchicoside and / or diclofenac potassium or any NSAID due to adverse reactions. 4. Subjects who have taken thiocolchicoside and / or diclofenac potassium in the 7 days prior to inclusion in the study. 5. Subjects suffering from severe systemic disease to more the muscle contracture. 6. Subjects who have taken any other medication for a specific medical condition or disease within the past 7 days before inclusion in the study. 7. Subjects with a history of: a. Convulsions, seizures or epilepsy risk b. Significant renal or hepatic function abnormal, which could compromise the welfare of the subjects or mask the results of the study, c. Gastrointestinal bleeding 8. Subjects as precautions, warnings or contraindications included in the monograph thiocolchicoside and / or diclofenac potassium and according to the investigator's opinion should not be included in the study 9. Subjects with a history of substance abuse or chronic alcohol abuse. 10. Pregnant or breast-feeding. 11. Women of childbearing age in which they may suspect the possibility of pregnancy (LMP, anamnesis and if necessary test to exclude pregnancy)

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

3

Target sample size:

90

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Ana

Middle Name:

María

Last Name:

Fallas Quezada

Affiliation:

Gutis Ltda.

Postal Address:

Zona industrial de Pavas, 300 metros al oeste de las oficinas centrales de Pizza Hut

City:

San Jose

Country:

Costa Rica

Zip Code:

Apdo. 5391-1000

Telephone:

+(506) 2549 8300

Email :

a.fallas@gutis.com

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Iván

Middle Name:

Neptalí

Last Name:

Guayasamín Landázuri

Affiliation:

Gutisfarmacéutica Ecuador S.A.

Postal Address:

Av. De los Shyris N35-71 y Suecia, Edificio Argentum, 13avo piso, Oficinas 1304, 1305

City:

Quito

Country:

Ecuador

Zip Code:

Not entered

Telephone:

+(593) 2 3333555

Email :

iguayasamin@yahoo.com

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000162

Date of Registration in Primary Registry:

2013-06-20

Record Verification Date:

2013-06-14

Next update date:

2014-06-14

Link to the spanish version:

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Registered Trials

Registration process

CONTROLLED, DOUBLE-BLIND, RANDOMIZED, MULTICENTER, FASE IIIb TRIAL DESIGNED TO EVALUATE THE EFFICACY AND TOLERABILITY OF THE FIXED COMBINATION OF THIOCOLCHICOSIDE PLUS DICLOFENAC POTASSIUM IN ACUTE PAINFUL MUSCLE CONTRACTURE

About the RPCEC

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