RDD1609 (Pregabalin Gel) for Pruritus Ani
Research type
Research Study
Full title
RDD1609 (Pregabalin Gel) as a Treatment for Idiopathic Pruritus Ani: A Randomized Double Blinded Placebo Controlled Crossover Study
IRAS ID
257242
Contact name
Robert Shleypak
Contact email
Sponsor organisation
RDD Pharma. LTD
Eudract number
2018-004259-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 17 days
Research summary
Subjects who have itching in skin surrounding the anus and the study doctor diagnosed them as suffering from Idiopathic Pruritis Ani will be recruited. Currently, there are no medications approved for the treatment of idiopathic pruritus ani, and we believe that Pregabalin Gel may be a suitable treatment for this condition.
We plan to include approximately 24 participants with Idiopathic Pruritis Ani from 4 hospitals and clinics across the UK
In this study all patients will receive active drug treatment. However, neither subject nor study staff will know which treatment group a subject is in. Some patients may start drug treatment at the beginning of the study and will be treated until the middle of the study, while others will start drug treatment only in the middle of the study. During the time subjects are not treated, they will receive placebo. This is sometimes called the ‘dummy medicine’. It looks the same as the treatment but does not contain any of the real drug and will have no effect on subject.
In total the treatment period will take 6 weeks.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
19/WM/0049
Date of REC Opinion
14 May 2019
REC opinion
Further Information Favourable Opinion