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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00624845
Double-Blind, Multicenter, Study Comparing the Efficacy and Safety of OMS103HP With Vehicle Irrigation Solution in Subjects Undergoing Meniscectomy (C07-004)
17 de junio de 2011 actualizado por: Omeros Corporation
Double-Blind, Multicenter, Study Comparing the Efficacy and Safety of OMS103HP
The purpose of this study is to assess the benefit of OMS103HP for Injection (OMS103HP) compared with vehicle irrigation solution for prevention of pain and pain relief in subjects undergoing meniscectomy.
The pain relief is assessed based on Visual Analog Scale (VAS) Pain Scores in the immediate 24-hour postoperative period and for seven days postoperatively.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
200
Fase
- Fase 2
- Fase 3
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
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Arizona
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Tucson, Arizona, Estados Unidos, 85712
- Tucson Orthopaedic Institute
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Tucson, Arizona, Estados Unidos, 85712
- Visions Clinical Research
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California
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Los Angeles, California, Estados Unidos, 90045
- Kerlan-Jobe Orthopaedic Clinic - Westchester
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Colorado
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Aurora, Colorado, Estados Unidos, 80014
- Advanced Orthopedic and Sports Medicine Specialists
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Englewood, Colorado, Estados Unidos, 80110
- Colorado Orthopedic Consultants
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Maryland
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Baltimore, Maryland, Estados Unidos, 21218
- Greater Chesapeake Orthopaedic Associates
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Pennsylvania
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State College, Pennsylvania, Estados Unidos, 16801
- University Orthopedics Center
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Texas
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San Antonio, Texas, Estados Unidos, 78217
- Unlimited Research
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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
Inclusion Criteria:
- Subject has voluntarily signed informed consent form, including HIPAA Authorization.
- Subject is ≥ 18 and ≤ 75 years of age.
- Subject is in good general health with a traumatic or degenerative meniscal cartilage injury (full tear) that occurred at least 14 days prior to the day of arthroscopic surgery.
- Subject is undergoing unilateral meniscectomy.
- Subject's physical examination is within normal limits or examination is clinically nonsignificant as determined by the Investigator, and subject is in good general health.
- Subject's laboratory evaluations are within normal limits or evaluations are clinically nonsignificant as determined by the Investigator.
- Subject, if female and of childbearing potential (i.e., not surgically sterilized or post-menopausal greater than one year) agrees to use an effective method of birth control for the duration of her study involvement.
- Subject is at minimal risk from anesthesia and is classified according to the American Society of Anesthesiologists Physical Status Classification as either PS-1 (a normal healthy patient) or PS-2 (a patient with mild systemic disease that results in no functional limitation). See Appendix VI.
- Subject agrees to refrain from taking the excluded medications listed in Exclusion Criteria through postoperative Day 7 (except for authorized analgesic medications) unless written permission has been granted by Omeros.
- Subject is able to be proficient in the use of the ePRO device (documented at the site).
Exclusion Criteria:
- Subject with significant arthritis (>2 on the Kellgren-Lawrence Scale).
- Subject with a history of reactive synovial disease.
- Subject with current, or history of, complex regional pain syndrome (Type I, i.e., reflex sympathetic dystrophy, or Type II, i.e., causalgia), chronic pain, attendance at a chronic pain clinic, or neurologic disorder associated with any sensory deficit of the lower extremities.
- Subject with current, or history of fibromyalgia.
- Subject taking ANY ANALGESIC (including salicylates, opioids, propoxyphene, etc.) on the day of surgery from 12:00 A.M. until after the procedure, except for medications authorized by the Investigator or delegated staff.
Subject taking any of the following medications within the stated time frames prior to the day of surgery.
- Amitriptyline within 30 days
- More than two doses of sumatriptan, (or any other drug in the triptan class), ondansetron, or other prescription serotonergic or histaminic drug within 14 days
- More than two doses of any oral, parenteral, or intravenous steroids (e.g., dexamethasone for antiemetic prophylaxis) within 3 months
- More than two doses of oxymetazoline or other nasal decongestant/cold/cough/allergy medication (including loratadine) within 7 days
- More than two doses of ketoprofen or other NSAID (including COX-2 inhibitors) within 7 days (except for piroxicam, as indicated below)
- Subject who has taken more than two doses of opioid pain medication within the prior seven days of surgery or chronic use of opioid pain medications for greater than 6 weeks within the prior year
- More than two doses of piroxicam within 14 days
- Subject with a history of intra-articular corticosteroid injection in the operative knee within the two months prior to the meniscectomy
Subject expected to undergo any of the following procedures concurrent with meniscectomy:
- Arthroscopic patellar tendon debridement
- Patellar alignment
- Lateral or retinacular release
- Excision synovectomy (minor synovectomy to improve arthroscopic visualization is acceptable)
- Concurrent ligamentous procedure
- Microfracture
- Abrasion arthroplasty
- Chondral transplantation
- Use of more than three portals
- Subject with allergies to any of the individual ingredients in OMS103HP, to related compounds (e.g., other NSAIDs or tricyclic antidepressants), or to opioid analgesics.
- Subject who is pregnant or breast-feeding.
- Subject with Worker's Compensation claim(s) under dispute or mediation.
- Subject with history of drug or alcohol abuse.
- Subject who has taken or used an investigational drug or device within 30 days prior to the day of surgery.
- Subject with a history or presence of systemic disease (renal, hepatic, psychiatric, etc.), which in the opinion of the Medical Monitor and the Principal Investigator, may place the subject's health at risk by participation in the study.
- Subject who is expected to receive a regional block for analgesia for this procedure.
- Subject who is considered by the Investigator for any reason to be an unsuitable candidate for receipt of an investigational drug.
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Vehículo
|
Maximum of 6 bags of vehicle irrigation solution
|
Experimental: Droga
|
Maximum 6 bags of OMS103HP irrigation solution
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
The primary efficacy endpoint is the mean VAS at 24 hours postoperatively.
Periodo de tiempo: 24 hours
|
24 hours
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Scott Houston, Omeros Corporation
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
1 de diciembre de 2007
Finalización primaria (Actual)
1 de mayo de 2009
Finalización del estudio (Actual)
1 de mayo de 2009
Fechas de registro del estudio
Enviado por primera vez
19 de febrero de 2008
Primero enviado que cumplió con los criterios de control de calidad
26 de febrero de 2008
Publicado por primera vez (Estimar)
27 de febrero de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
27 de junio de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
17 de junio de 2011
Última verificación
1 de junio de 2011
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- C07-004
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. .
Ensayos clínicos sobre OMS103HP
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Omeros CorporationTerminadoDesgarro de meniscoEstados Unidos