NCT00933465

Imodium Syrup Versus Imodium Tablets for Faecal Incontinence

Single Blinded Randomised Cross-over Study of Imodium Tablets Versus Imodium Syrup for the Treatment of Faecal Incontinence

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital Southampton NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DRUG	Imodium (Loperamide Hydrochloride) syrup	syrup (orally), max dose per day; 16x 5ml spoonfuls (80ml) Titrated from low dose to clinically relevant dose as described by the patient and their symptoms. Taken at times suitable for the patient, either at regular intervals as defined by patient needs, or as single dose when needed the most.
DRUG	Imodium (Loperamide hydrochloride) tablets	tablets (orally) max dose per day; in chronic diarrhea, 8 capsules (16 mg) titrated from low dose to clinically relevant dose as described by patient and their symptoms. Taken at times suitable for the patient, either at regular intervals as defined by patient needs, or as single dose when needed the most

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-07-07
• Last updated: 2014-11-18

Locations

1 site across 1 country: United Kingdom