A phase I trial to assess NRL001 in faecal incontinence patients. V1.0

• Research type

  Research Study

• Full title

  A double-blind, randomized, placebo-controlled, cross over study in patient volunteers with faecal incontinence to evaluate the effect on rectal compliance, rectal sensitivity, recto-anal inhibitory reflex, sphincter pressures, safety and tolerability of a daily rectal application of a 10mg NRL001 suppository for seven consecutive days

• IRAS ID

  53221

• Contact name

  Alastair Simpson

• Sponsor organisation

  Norgine Limited

• Eudract number

  2010-019771-30

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Doctors at the Department of Surgery are interested in helping people who are suffering from faecal incontinence. Faecal incontinence is the inability to control the passage of faecal material from the anus. There are a number of causes but one of the most common is weakness of the muscles surrounding the anal canal. The drug NRL001 may be able to tighten these muscles. In this study we will measure how the drug affects the tightness of the muscles in the anal canal and other parts of the system that control continence, both before and after taking the drug, as well as measuring levels of drug in the body and safety parameters.Participants with symptoms of faecal incontinence will be recruited from the Department of Surgery patient database or following GP referral. There will be up to 30 people participating in this single centre in Nottingham.The trial will first involve a screening procedure to ensure that volunteers are fit enough to participate in the study and that their symptoms are suitable for this trial. Following screening the trial will involve one week of administering a daily rectal suppository with an all day assessment in the hospital on the first and last day of the week and a 1hr safety check in the middle of the week. There will then be a break for at least 3 days, without rectal suppositories, followed by a further week repeating the suppository treatment and assessments. On one of the weeks participants will receive drug and on the other they will receive placebo suppositories (with no drug).The assessments involve the use of a rectal catheter to monitor pressure changes before and after taking the suppository, regular blood samples will also be taken on the assessment days.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  10/H0703/57

• Date of REC Opinion

  12 Jul 2010

• REC opinion

  Further Information Favourable Opinion