NRL001 in patients with faecal incontinence

• Research type

  Research Study

• Full title

  A multi-centre, phase II, double-blind, randomised, placebo-controlled, parallel group, dose-ranging study in patients with faecal incontinence; to evaluate the efficacy, safety and tolerability of locally applied NRL001 over an 8 week treatment period.

• IRAS ID

  89972

• Contact name

  Steven Brown

• Sponsor organisation

  Norgine Ltd

• Eudract number

  2011-003206-25

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Faecal incontinence involves the involuntary loss of faeces or gas from the anus. This can result in embarrassment, distress and a reduced quality of life. The cause of the incontinence can be physical damage to the anus such as from childbirth, or a reduction in the strength of the muscle in the anus. Current treatments available are limited in their effectiveness and surgery is often the only option. NRL001 is a new drug being developed for the treatment of faecal incontinence. NRL001 stimulates the nerves involved in muscle activity and if applied locally to the anus, is hoped to stimulate muscle activity in the anus. To date, NRL001 has been investigated in 12 clinical studies involving 394 healthy volunteers and patients with faecal incontinence. This clinical study hopes to enrol 580 patients from across 9 EU countries. The aim is to show the efficacy, safety and tolerability of NRL001 when given as a daily suppository for eight weeks. Patients will be allocated at random to 1 of 3 doses of NRL001 (5, 7.5 or 10 mg NRL001) or to placebo. The different doses of NRL001 will be given to identify the best dose strength for the improvement of faecal incontinence.Patients will be asked to attend the research site for 5 visits and then receive a follow up telephone call. They will be asked to complete questionnaires during their visits regarding the episodes of incontinence between visits. They will also have an electronic diary which they will complete on a daily basis with the details of when they took the study drug and details of any faecal incontinence episodes experienced. Their safety will be monitored throughout the study with regular ECGs, lab tests, clinical examinations and adverse event monitoring.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  11/EM/0417

• Date of REC Opinion

  3 Jan 2012

• REC opinion

  Further Information Favourable Opinion