To Evaluate if the Medication Gabapentin Lessens Vulvar Pain
Açar sözlər
Mücərrəd
Təsvir
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.
Tarixlər
| Son Doğrulandı: | 06/30/2017 |
| İlk təqdim: | 10/17/2006 |
| Təxmini qeydiyyat təqdim edildi: | 10/17/2006 |
| İlk Göndərmə: | 10/18/2006 |
| Son Yeniləmə Göndərildi: | 07/27/2017 |
| Son Yeniləmə Göndərildi: | 07/30/2017 |
| İlk təqdim edilmiş nəticələrin tarixi: | 03/29/2017 |
| İlk təqdim edilmiş QC nəticələrinin tarixi: | 07/27/2017 |
| İlk göndərilən nəticələrin tarixi: | 07/30/2017 |
| Həqiqi Təhsilin Başlama Tarixi: | 12/31/2006 |
| Təxmini İlkin Tamamlanma Tarixi: | 02/29/2008 |
| Təxmini İşin Tamamlanma Tarixi: | 02/29/2008 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Drug: Gabapentin
Drug: Placebo oral capsule
Faza
Qol Qrupları
| Qol | Müdaxilə / müalicə |
|---|---|
| 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. |
Uyğunluq Kriteriyaları
| Təhsil üçün uyğun yaşlar | 18 Years Üçün 18 Years |
| Təhsilə Uyğun Cinslər | Female |
| Sağlam Könüllüləri qəbul edir | Bəli |
| Kriteriyalar | 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). |
Nəticə
İlkin nəticə tədbirləri
1. Change From Baseline in Vulvar Pain [19 weeks]
