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Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer (MEDOR)

25 de marzo de 2021 actualizado por: Institut Bergonié

Evaluation of the Effectiveness of the Radiofrequency Ablation for Reducing Refractory Pain From Bone Metastases

RATIONALE: Morphine may reduce pain in patients who have undergone radiofrequency ablation to remove bone metastases.

PURPOSE: This phase II trial is studying how well morphine works after radiofrequency ablation of painful bone metastases in patients with cancer.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

OBJECTIVES:

Primary

  • Measure the efficacy of morphine sulfate at 8 weeks after radiofrequency ablation (RFA) of bone metastases.

Secondary

  • Assess minimum and average pain and analyze use of morphine sulfate before and after RFA.
  • Determine disease progression by CT scan of bone.
  • Evaluate the percentage of relief associated with RFA, specifically patient satisfaction, quality of life, anxiety, depression, and physical performance during RFA.
  • Assess complications and side effects related to RFA and the evolution of possible side effects associated with morphine sulfate therapy.

OUTLINE: This is a multicenter study.

Patients complete a pain questionnaire over 1 week before undergoing radiofrequency ablation (RFA). Patients also complete questionnaires about pain, physical performance, quality of life (QOL), and anxiety at baseline.

Bone metastases are removed by radiofrequency ablation (RFA). After surgery, patients receive acetaminophen and patient-controlled analgesic (PCA) morphine sulfate. PCA morphine sulfate continues with a dose increase of 50% bolus every 24 hours. Patients with maximum pain less than or equal to that at inclusion receive standard morphine sulfate therapy instead.

Data concerning the total dose of PCA morphine sulfate; minimum, average, and maximum pain intensity; side effects and complications of RFA; and total dose of morphine sulfate (or equivalent) is collected daily.

Pain is assessed at 4 and 8 weeks after RFA. Patients complete follow-up questionnaires about physical performance, QOL, and anxiety at 12 weeks. Patients also undergo a CT scan at 12 weeks.

Tipo de estudio

Intervencionista

Inscripción (Actual)

78

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Francia
      • Bordeaux, Francia, 33076
        • Institute Bergonie

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

DISEASE CHARACTERISTICS:

  • Histologically confirmed cancer

    • Primary or unknown origin

  • Painful bone metastases despite radiotherapy or symptomatic relapse into previously irradiated area with no possibility of repeating radiotherapy

    • Bone metastases may have been treated with bisphosphonates

    • Osteolytic bone or joint (lytic and condensed) confirmed by CT scan and meeting the following criteria:

      • Lesion size ≤ 5 cm

      • No more than 2 painful bone metastases

        • If 2 lesions are to be treated, distinct anatomical locations can be treated at the same time
      • Metastatic bone lesions of the pelvis, sacrum (in absence of canal involvement), ribs, or long bones allowed
    • Pain located at the tumor or in the area
  • Maximum pain in the last 24 hours > 4 points (numerical scale to 11 points)

PATIENT CHARACTERISTICS:

  • Life expectancy > 3 months
  • Platelet count > 50,000/μL
  • Prothrombin < 50%
  • Activated cephalin time ≤ 1.5 times normal
  • Not pregnant
  • Fertile patients must use effective contraception
  • No geographical, social, or psychiatric reason that would preclude follow up

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • At least 3 weeks since prior chemotherapy or bisphosphonates
  • At least 1 week since beginning new painkiller therapy or anticoagulation treatment
  • More than 30 days since participation in another drug study
  • More than 30 days since prior surgery

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Patient who has undergone radiofrequency ablation of bone metastases
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
Droga: Acetaminophen
Intravenous administration of paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).
Otros nombres:
  • Paracetamol
Droga: Morphine Sulfate
Patient-controlled analgesia (PCA), allowing morphine consumption to be titrated to the patient's needs and thus allowing morphine doses to be adapted to an increase in pain in the patient's post-operative period or a rapid analgesic effect of radiofrequency.
Otros nombres:
  • Oral morphine equivalent
Otro: Questionnaire administration

Pain notebook will allow the patient to describe the pain specific to the metastasis concerned, containing information on :

  • The intensity of the minimum, average and maximum pain of the last 24 months. hours as well as the intensity of the pain of the moment according to a scale 11-point digital,
  • the background morphine analgesic treatment during the last 24 hours,
  • the morphine analgesic treatment taken during painful attacks,
  • the possible undesirable effects of morphine treatment.
  • the morphinic, non-morphinic and co-antalgic treatment is noted, as well as that the total dose of oral morphine or oral morphine equivalent
Procedimiento: Quality-of-life assessment
Patients' quality of life will be assessed using the quality of life questionnaire EORTC QLQ-C30 at inclusion in the study and at 8 weeks after radiofrequency. ablation.
Procedimiento: Radiofrequency ablation

Recent technique of thermal destruction of tumors.

This technique consists of inserting an electrode needle into the tumour under X-ray or ultrasound guidance or intraoperatively under laparoscopy for example. This needle carries a current or a light wave depending on the characteristics of the generator to which it is connected (radiofrequency, laser).

Radio frequencies are radiation non-ionising electromagnets. In this context of tissue ablathermia wavelengths ranging from 400kHz to 500kHz.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA)
Periodo de tiempo: 2 months after radiofrequency ablation (RFA)

Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to an 11-point numerical scale

Rate of patients with a decrease of two or more points in their most intense pain, 2 months after the radiofrequency ablation.

This rate is calculated for the evaluable population for the principal outcome measure.

This rate is equal to the ratio of the number of patients with a decrease of two or more points in their maximum pain divided by the size of the evaluable population.

The response rate considered acceptable is 50%, above this threshold the treatment will be considered potentially effective and may be proposed in phase III.
2 months after radiofrequency ablation (RFA)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation
Periodo de tiempo: Inclusion and 2 months after radiofrequency ablation (RFA)

Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to a discrete 11-points numerical scale.

Increased/decreased pain is considered as a variation of at least one point on the numerical scale.

If 25 patients or more are observed with pain reduction of 2 or more points, then the treatment will be considered potentially effective.
Inclusion and 2 months after radiofrequency ablation (RFA)
Intensity of Pain (Minimum, Average, Maximum)
Periodo de tiempo: First algology assessment at pre-selection visit

According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.

Assessment of intensity of pain has been done in this order at:

  • Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,
  • Inclusion visit: Second algology assessment (One week after the first algology assessment)
  • J-1: one day before radiofrequency
  • J+1: One day after radiofrequency
  • Discharge from hospital
  • 7 days after discharge from hospital
  • 1 month after radiofrequency
  • 2 months after radiofrequency
  • 3 months after radiofrequency

Here, are presented only data collected at the pre-selection visit.
First algology assessment at pre-selection visit
Intensity of Pain (Minimum, Average, Maximum)
Periodo de tiempo: Second algology assessment at inclusion visit

According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.

Assessment of intensity of pain has been done in this order at:

  • Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,
  • Inclusion visit: Second algology assessment (One week after the first algology assessment)
  • J-1: one day before radiofrequency
  • J+1: One day after radiofrequency
  • Discharge from hospital
  • 7 days after discharge from hospital
  • 1 month after radiofrequency
  • 2 months after radiofrequency
  • 3 months after radiofrequency

Here, are presented only data collected at the inclusion visit.
Second algology assessment at inclusion visit
Intensity of Pain (Minimum, Average, Maximum)
Periodo de tiempo: Algology assessment one day before radiofrequency (J-1)

According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.

Assessment of intensity of pain has been done in this order at:

  • Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,
  • Inclusion visit: Second algology assessment (One week after the first algology assessment)
  • J-1: one day before radiofrequency
  • J+1: One day after radiofrequency
  • Discharge from hospital
  • 7 days after discharge from hospital
  • 1 month after radiofrequency
  • 2 months after radiofrequency
  • 3 months after radiofrequency

Here, are presented only data collected one day before radiofrequency (J-1).
Algology assessment one day before radiofrequency (J-1)
Intensity of Pain (Minimum, Average, Maximum)
Periodo de tiempo: Algology assessment one day after radiofrequency: J+1

According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.

Assessment of intensity of pain has been done in this order at:

  • Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,
  • Inclusion visit: Second algology assessment (One week after the first algology assessment)
  • J-1: one day before radiofrequency
  • J+1: One day after radiofrequency
  • Discharge from hospital
  • 7 days after discharge from hospital
  • 1 month after radiofrequency
  • 2 months after radiofrequency
  • 3 months after radiofrequency

Here, are presented only data collected one day after radiofrequency (J+1).
Algology assessment one day after radiofrequency: J+1
Intensity of Pain (Minimum, Average, Maximum)
Periodo de tiempo: Algology assessment at the discharge from hospital visit

According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.

Assessment of intensity of pain has been done in this order at:

  • Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,
  • Inclusion visit: Second algology assessment (One week after the first algology assessment)
  • J-1: one day before radiofrequency
  • J+1: One day after radiofrequency
  • Discharge from hospital
  • 7 days after discharge from hospital
  • 1 month after radiofrequency
  • 2 months after radiofrequency
  • 3 months after radiofrequency

Here, are presented only data collected at the discharge from hospital visit.
Algology assessment at the discharge from hospital visit
Intensity of Pain (Minimum, Average, Maximum)
Periodo de tiempo: Algology assessment 7 days after discharge from hospital

According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.

Assessment of intensity of pain has been done in this order at:

  • Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,
  • Inclusion visit: Second algology assessment (One week after the first algology assessment)
  • J-1: one day before radiofrequency
  • J+1: One day after radiofrequency
  • Discharge from hospital
  • 7 days after discharge from hospital
  • 1 month after radiofrequency
  • 2 months after radiofrequency
  • 3 months after radiofrequency

Here, are presented only data collected 7 days after discharge from hospital.
Algology assessment 7 days after discharge from hospital
Intensity of Pain (Minimum, Average, Maximum)
Periodo de tiempo: Algology assessment 1 month after radiofrequency

According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.

Assessment of intensity of pain has been done in this order at:

  • Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,
  • Inclusion visit: Second algology assessment (One week after the first algology assessment)
  • J-1: one day before radiofrequency
  • J+1: One day after radiofrequency
  • Discharge from hospital
  • 7 days after discharge from hospital
  • 1 month after radiofrequency
  • 2 months after radiofrequency
  • 3 months after radiofrequency

Here, are presented only data collected 1 month after radiofrequency.
Algology assessment 1 month after radiofrequency
Intensity of Pain (Minimum, Average, Maximum)
Periodo de tiempo: Algology assessment 2 months after radiofrequency

According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.

Assessment of intensity of pain has been done in this order at:

  • Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,
  • Inclusion visit: Second algology assessment (One week after the first algology assessment)
  • J-1: one day before radiofrequency
  • J+1: One day after radiofrequency
  • Discharge from hospital
  • 7 days after discharge from hospital
  • 1 month after radiofrequency
  • 2 months after radiofrequency
  • 3 months after radiofrequency

Here, are presented only data collected 2 months after radiofrequency.
Algology assessment 2 months after radiofrequency
Intensity of Pain (Minimum, Average, Maximum)
Periodo de tiempo: Algology assessment 3 months after radiofrequency

According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.

Assessment of intensity of pain has been done in this order at:

  • Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,
  • Inclusion visit: Second algology assessment (One week after the first algology assessment)
  • J-1: one day before radiofrequency
  • J+1: One day after radiofrequency
  • Discharge from hospital
  • 7 days after discharge from hospital
  • 1 month after radiofrequency
  • 2 months after radiofrequency
  • 3 months after radiofrequency

Here, are presented only data collected 3 months after radiofrequency.
Algology assessment 3 months after radiofrequency
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
Periodo de tiempo: Preselection: First algology visit (within a week (± 3 days) after the radiology consultation)

Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned.

In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day.

This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Preselection: First algology visit (within a week (± 3 days) after the radiology consultation)
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
Periodo de tiempo: Inclusion: Second algology visit (One week after the first algology visit)

Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned.

In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day.

This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Inclusion: Second algology visit (One week after the first algology visit)
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
Periodo de tiempo: J-1 (One day before radiofrequency)

Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned.

In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day.

This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
J-1 (One day before radiofrequency)
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
Periodo de tiempo: Discharge from hospital

Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned.

In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day.

This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Discharge from hospital
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
Periodo de tiempo: 7 days after discharge

Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned.

In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day.

This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
7 days after discharge
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
Periodo de tiempo: 1 month after radiofrequency

Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned.

In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day.

This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
1 month after radiofrequency
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
Periodo de tiempo: 2 months after radiofrequency

Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned.

In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day.

This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
2 months after radiofrequency
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
Periodo de tiempo: 3 months after radiofrequency

Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned.

In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day.

This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
3 months after radiofrequency
Total Intravenous Morphine Dose (mg)
Periodo de tiempo: 24 hours after radiofrequency

Total intravenous dose of morphine 24 hours after the radiofrequency was assessed during the patient's hospital stay.

As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).
24 hours after radiofrequency
Bolus Dose in mg Administered by Patient-controlled Analgesia (PCA)
Periodo de tiempo: 24 hours after radiofrequency
As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).
24 hours after radiofrequency
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Periodo de tiempo: Inclusion

Quality of life Questionnaire -Core 30 (QLQ-C30) developed in 1986 by the European Organization for Research and Treatment of Cancer (EORTC) assesses quality of life across 15 dimensions :

5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties;

1 global health dimension: Global health status/QoL

Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health.
Inclusion
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Periodo de tiempo: 2 months after radiofrequency

Quality of life Questionnaire -Core 30 (QLQ-C30) developed in 1986 by the European Organization for Research and Treatment of Cancer (EORTC) assesses quality of life across 15 dimensions :

5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties;

1 global health dimension: Global health status/QoL

Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health.
2 months after radiofrequency

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Institut Bergonié

Investigadores

  • Silla de estudio: Florence Dixmerias, MD, Institut Bergonie

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

24 de diciembre de 2007

Finalización primaria (Actual)

11 de febrero de 2016

Finalización del estudio (Actual)

16 de marzo de 2016

Fechas de registro del estudio

Enviado por primera vez

9 de julio de 2008

Primero enviado que cumplió con los criterios de control de calidad

9 de julio de 2008

Publicado por primera vez (Estimar)

10 de julio de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de marzo de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

25 de marzo de 2021

Última verificación

1 de marzo de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CDR0000589594
  • IB-MEDOR (Otro identificador: Institute Bergonie)
  • IB-2007-16 (Otro identificador: Institute Bergonie)
  • INCA-RECF0498 (Otro número de subvención/financiamiento: INCA)
  • 2007-002686-13 (Número EudraCT)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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