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

• Register: RPCEC
• Last refreshed on: 1 April 2024
• Main ID: RPCEC00000162
• Date of registration: 20/06/2013
• Prospective Registration: No
• Primary sponsor: Gutis Ltda. San Jose, Costa Rica
• Public title: 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
• 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
• Date of first enrolment: 15/04/2012
• Target sample size: 90
• Recruitment status: Complete
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000162-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
• Phase: 3

Countries of recruitment

Ecuador

Contacts

• Name: Iván Neptalí Guayasamín Landázuri
• Affiliation: Gutisfarmacéutica Ecuador S.A.

• Name: Ana María Fallas Quezada
• Affiliation: Gutis Ltda.

Key inclusion & exclusion criteria

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)

Age minimum: 18 years
Age maximum: 59 years
Gender: Male/Female

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

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)

Secondary Outcome(s)

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)

Secondary ID(s)

ECU-CONP-01

Source(s) of Monetary Support

Gutis Ltda. San Jose, Costa Rica

Secondary Sponsor(s)

Not applicable