A Phase III Double-Blind Equivalence Study of Two Different Formulations of Slow-Release Morphine Followed by a Randomization Between Dextromethorphan or Placebo Plus Statex SR for Chronic Cancer Pain Relief in Terminally Ill Patients
dextromethorphan hydrobromide
+ morphine sulfate
Linfadenopatía+66
+ Amiloidosis
+ Trastornos de la coagulación de la sangre
Estudio de Cuidados de Apoyo
Resumen
Fecha de inicio: 11 de junio de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: Compare the analgesic efficacy of two formulations of morphine (Statex SR versus MS-Contin) in patients requiring morphine for the treatment of chronic cancer pain. Compare the effect of these 2 formulations of morphine on the total analgesic consumption, sleep disturbances, sleep and nausea, responses of different types of pain, and toxic effects experienced in the two treatment groups. Compare the effect of coadministration of morphine and dextromethorphan versus morphine and placebo on pain control in the respective patient groups (phase B). Compare the effect of morphine and dextromethorphan or placebo on total analgesic consumption, sleep disturbances, sleep and nausea, responses of different types of pain, and toxic effects on the two treatment groups (phase B). OUTLINE: This is a randomized, double-blind, parallel-group, multicenter study. Patients are stratified by stabilization dose (less than 120 mg/day vs greater than 120 mg/day of morphine) and institution in phase A, and neuropathic pain (yes vs no) in phase B. Phase A: Patients are randomized to receive oral morphine in one of two formulations (MS Contin or Statex SR) every 12 hours for 7 days. Phase B: Eligible patients from phase A who have taken no more than 2 breakthrough doses of analgesic per day in the previous 2 days are re-randomized to receive dose escalated oral dextromethorphan capsules or placebo every 4 hours, and oral morphine tablets every 12 hours for 14 days. Phase C: All patients fulfilling entry criteria at the end of phase A or any time during phase B may receive compassionate use morphine tablets for up to 90 days. Patients complete a pain diary twice each day during treatment.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 87 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Cuidados de Apoyo
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 16 a 120 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Histologically or cytologically proven advanced cancer with chronic pain Cancer pain requiring strong opioids having an average pain score of less than 6/10 on the visual analog scale within last 24 hours Pain managed by a stable maintenance dose of MS-Contin formulation of morphine for at least 2 days with no more than 2 breakthrough immediate release morphine doses per 24 hours Pain that is expected to be controlled by a stable and adequate total daily dose of sustained release morphine for the first 7 days of the study PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: SGOT or SGPT no greater than 3 times upper limit of normal (ULN) No liver disease Renal: Creatinine no greater than 2 times ULN No kidney failure Pulmonary: No clinically significant respiratory depression No severe obstructive airway disease Other: Fluent in English or French No known hypersensitivity or allergy to study medications or components or other multiple drug allergies Normal cognition defined by the Folstein Mini-Mental State Questionnaire (at least 24/30 correct) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 14 days since prior chemotherapy Endocrine therapy: Concurrent steroids allowed Radiotherapy: At least 14 days since prior analgesic radiotherapy Surgery: Not specified Other: At least 3 months since prior investigational agents At least 1 month since prior clinical study No concurrent analgesics other than morphine No other concurrent medications containing dextromethorphan Concurrent antidepressant medication allowed Concurrent nonsteroidal antiinflammatory drugs allowed At least 14 days since prior monoamine oxidase (MAO) inhibitors No concurrent MAO inhibitors
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 4 ubicaciones
Newfoundland Cancer Treatment and Research Foundation
St. John's, CanadaPrincess Margaret Hospital
Toronto, CanadaMcGill University
Montreal, Canada