![]() ![]() ![]() Pacientes con diagnostico clínico y electrofisiológico de STC en los que no se prevea tratamiento quirúrgico precoz.ģ. Pacientes de edad entre 18 años y 80 años.Ģ. Para ello se utilizaran escalas de dolor y de cuantificación de síntomas sensitivos positivos.ġ) To evaluate the improvement of life quality measured by SF36 test.Ģ) To evaluate the improvement of electrophysiologic parametes according to sensitive conduction in carpal tunnel, distal motor latency, as well as motor and sensory potential amplitude.ģ) To evaluate the safety of the treatment with CMP Forte in patients with pain due to CTS.ġ-Evaluar la mejora de la calidad de vida a través del test SF 36.Ģ-Evaluar la mejora de los parámetros ectrofisiológicos a través de la velocidad de conducción sensitiva en canal del carpo, latencia motora distal, así como amplitud de potencial sensitivo y motor.ģ- Evaluar la seguridad del tratamiento CMP forte en el tratamiento del dolor en pacientes con STC.Ģ) Patients clinically and electrophysiological diagnosed with CTS, who won?t require a premature surgical procedure.ģ) Patients able to understand the study objective and able to give the Inform Consent.ġ. Forte en la sintomatología del paciente con STC. To evaluate the treatment of symptoms with Nucleo CMP Forte in patients diagnosed with CTS, using pain escales and quantification of sensitive positive symptomsĮvaluar la eficacia del tratamiento con Núcleo C.M.P. Síndrome del túnel carpiano (STC): patología más frecuente por compresión nerviosa crónicaĭiseases - Nervous System Diseases Į.1.2 Medical condition or disease under investigationĬondition being studied is a rare disease Medical condition in easily understood languageĬarpal Tunnel Syndrome: more frequently pathology due to chronic medium nerve compression. Medicinal product containing genetically modified organismsĮ.1 Medical condition or disease under investigation Immunological medicinal product (such as vaccine, allergen, immune serum) one involving a medical device)Ĭommittee on Advanced therapies (CAT) has issued a classification for this productĬombination product that includes a device, but does not involve an Advanced Therapy The IMP has been designated in this indication as an orphan drug in the Communityĭ.3.8 to D.3.10 IMP Identification Details (Active Substances)Īctive substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)Ĭombination ATIMP (i.e. Name of the Marketing Authorisation holderĬountry which granted the Marketing Authorisation IMP to be used in the trial has a marketing authorisation Status of the IMP to be used in the clinical trial Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). ![]() The register also displays information on The EU Clinical Trials Register currently displaysĬlinical trials with a EudraCT protocol, of whichĪre clinical trials conducted with subjects less than 18 years old. Interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/ECĬlinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine developmentĮU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through theĬlinical Trials Information System (CTIS). Allows you to search for protocol and results information on: ![]()
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