Imodium Syrup Versus Imodium Tablets for Faecal Incontinence

Status Withdrawn

Clinical Trial Summary

Faecal incontinence (FI) is a debilitating and often neglected problem. It can be defined as the loss of voluntary control of liquid or solid stool.It is estimated that 2-3% of western adults suffer from FI with prevalence increasing with age, further to this up to 50% of nursing home residents suffer too with it more common in females. Aetiology is often multi-factoral, where obstetric anal sphincter injury is most common is females and iatrogenic anal sphincter injury is most common in males.

Loperamide (imodium) is a constipating agent used as first choice pharmacological agent due to its high efficacy. Trials have suggested it thickens stool consistency and may raise resting anal sphincter pressure, associated with improved clinical function with a reduction in bowel frequency and urgency, a reduction in incontinence and less need for pads.

Loperamide is well tolerated but has been known to cause side effects of abdominal pain and distension, nausea and vomiting and constipation.

Imodium can be taken in two ways; as syrup (1mg/5mls) or tablets (2mg). There have been no comparative studies. Side effects are mainly seen with the tablet form and so it is hypothesized that the syrup form is better tolerated because it is more accurately titrated to effect.

This is a NHS funded single blinded, randomised, cross-over study to assess the clinical effects of Imodium, in tablet and syrup form, on patients presenting with faecal incontinence. Each subject will act as their own control. Patients will be recruited through out-patient visits for their FI, where they will be made aware of the trial. During the trial they will be asked to fill out FI scoring questionnaires and quality of life scores. Also they will undertake two assessments of anal physiology testing squeeze pressures, sensation and compliance at baseline and at the end after three months.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Fecal Incontinence

Clinical Trial Details

NCT number	NCT00933465
Study type	Interventional
Source	University Hospital Southampton NHS Foundation Trust.
Contact
Status	Withdrawn
Phase	Phase 4
Start date	October 2009
Completion date	May 2010

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.