To Evaluate if the Medication Gabapentin Lessens Vulvar Pain
Anahtar kelimeler
Öz
Açıklama
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.
Tarih
| Son Doğrulandı: | 06/30/2017 |
| İlk Gönderilen: | 10/17/2006 |
| Tahmini Kayıt Gönderildi: | 10/17/2006 |
| İlk Gönderilen: | 10/18/2006 |
| Son Güncelleme Gönderildi: | 07/27/2017 |
| Son Güncelleme Gönderildi: | 07/30/2017 |
| İlk gönderilen sonuçların tarihi: | 03/29/2017 |
| QC sonuçlarının ilk gönderildiği tarih: | 07/27/2017 |
| İlk yayınlanan sonuçların tarihi: | 07/30/2017 |
| Fiili Çalışma Başlangıç Tarihi: | 12/31/2006 |
| Tahmini Birincil Tamamlanma Tarihi: | 02/29/2008 |
| Tahmini Çalışma Tamamlanma Tarihi: | 02/29/2008 |
Durum veya hastalık
Müdahale / tedavi
Drug: Gabapentin
Drug: Placebo oral capsule
Evre
Kol Grupları
| Kol | Müdahale / tedavi |
|---|---|
| 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. |
Uygunluk kriterleri
| Çalışmaya Uygun Yaşlar | 18 Years İçin 18 Years |
| Çalışmaya Uygun Cinsiyetler | Female |
| Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
| Kriterler | 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). |
Sonuç
Birincil Sonuç Ölçütleri
1. Change From Baseline in Vulvar Pain [19 weeks]
