IXA-CSP-001 Litoxetine v Placebo in Urinary Incontinence 2016-12-09 V1
Research type
Research Study
Full title
A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group, Phase 2, Dose Ranging Trial to Evaluate the Efficacy, Safety, and Tolerability of Oral Litoxetine 10mg,20mg and 40mg Twice Daily (BID) versus Placebo in Women with Mixed Urinary Incontinence
IRAS ID
222475
Contact name
Dudley Robinson
Contact email
Sponsor organisation
Ixaltis SAS
Eudract number
2016-004307-30
Clinicaltrials.gov Identifier
VHP-No: VHP1022 (VHP2016175), VHP REFERENCE NUMBER
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
The purpose of the study is to see how 3 different strengths of Litoxetine versus placebo works to treat Mixed Urinary Incontinence (MUI) in female patients who have been diagnosed with MUI. Litoxetine, the study drug, is a selective serotonin (5-HT) reuptake inhibitor (SSRI). Serotonin is a compound present in the blood platelets that acts as a neurotransmitter (it helps to pass messages between nerves in the body). Serotonin plays an important role in controlling the reflexes which cause patients to urinate. Litoxetine has an effect on the way serotonin is used by the nerves in the body, including those which affect the bladder. This effect has been shown to act on the muscles in the bladder which may be of benefit and this study will allow us to test whether or not this effect will result in an improvement in bladder symptoms. Female patients aged between 18-75 will be recruited from hospitals in the UK and up to 6 other countries. Patients will be on the study for 147 days (21 weeks) and have a 75% chance of being on a low, medium, or high dose of Litoxetine and a 25% chance of being on placebo
The study requires the participants to have 7 clinic visits and to complete an electronic diary daily to monitor their continence issues. Procedures include monitoring of general health, the heart, blood analysis, ultrasound scans of the bladder and completion of health questionnaires. The Study is sponsored by Ixaltis.
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/0304
Date of REC Opinion
2 Mar 2017
REC opinion
Favourable Opinion