To Evaluate if the Medication Gabapentin Lessens Vulvar Pain
Palabras clave
Abstracto
Descripción
There is not a "best" treatment plan for vulvar pain including vulvodynia (chronic vulvar pain) and vulvar vestibulitis syndrome (VVS, chronic vulvar pain localized to the vaginal opening). We propose that vulvodynia is a neuropathic pain (pain that effects the nervous system) as characterized by pain from stimuli that is not usually painful, stimuli that would not usually be painful causing significant pain, and burning pain. Gabapentin has been shown to be effective in treating chronic pain.
fechas
| Verificado por última vez: | 06/30/2017 |
| Primero enviado: | 10/17/2006 |
| Inscripción estimada enviada: | 10/17/2006 |
| Publicado por primera vez: | 10/18/2006 |
| Última actualización enviada: | 07/27/2017 |
| Última actualización publicada: | 07/30/2017 |
| Fecha de los primeros resultados enviados: | 03/29/2017 |
| Fecha de los primeros resultados de CC enviados: | 07/27/2017 |
| Fecha de los primeros resultados publicados: | 07/30/2017 |
| Fecha de inicio real del estudio: | 12/31/2006 |
| Fecha estimada de finalización primaria: | 02/29/2008 |
| Fecha estimada de finalización del estudio: | 02/29/2008 |
Condición o enfermedad
Intervención / tratamiento
Drug: Gabapentin
Drug: Placebo oral capsule
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: Gabapentin Gabapentin (Neurontin) titration and dosing for total of 8 weeks (Cross over) | Drug: Gabapentin 300 mg. capsules
Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
day 1 you will take 1 capsule for the day
day 2 you will take 1 capsule 2 times for that day
days 3-6 you will take 1 capsule 3 times for those days
days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
days 13-14 you will take 2 capsules 3 times each day
continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
at completion of study treatment you will titrate off study drug over a weeks time. |
| Placebo Comparator: Placebo oral capsule Placebo titration and dosing for total of 8 weeks (Cross over) | Drug: Placebo oral capsule Placebo capsules
Dosage schedule for weeks 1 and 2 and weeks 12 and 13:
day 1 you will take 1 capsule for the day
day 2 you will take 1 capsule 2 times for that day
days 3-6 you will take 1 capsule 3 times for those days
days 7-9 you will take 1 capsule in am and 1 capsule at noon, 2 capsules at bedtime each day
days 10-12 you will take 1 capsule in am and 2 capsules at noon and 2 capsules at bedtime each day
days 13-14 you will take 2 capsules 3 times each day
continue on 2 capsules 3 times each day for 6 weeks after maximum dose of 1800 mg is reached after weeks 2 and 13.
at completion of study treatment you will titrate off study drug over a weeks time. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | Female |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - All women, ages 18 years and older with the diagnosis of vulvodynia or VVS (by Friedrich's criteria), who present to the University of Iowa Vulvar Vaginal Disease Clinic. Exclusion Criteria: - Vulvar Vaginal Disease clinic patients who are pregnant, less than 3 months postpartum, breast-feeding, non-English speaking, or have contraindication to use of gabapentin due to allergy or renal disease (serum creatinine level greater than 1.4). |
Salir
Medidas de resultado primarias
1. Change From Baseline in Vulvar Pain [19 weeks]
