Imodium Syrup Versus Imodium Tablets for Faecal Incontinence

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00933465
• Other study ID #: RHMMED0874
• Secondary ID: eudraCT number
• Status: Withdrawn
• Phase: Phase 4
• First received: July 3, 2009
• Last updated: November 17, 2014
• Start date: October 2009
• Est. completion date: May 2010

Study information

• Verified date: November 2014
• Source: University Hospital Southampton NHS Foundation Trust.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health Service
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Aged 18 - 75

• Severe faecal incontinence defined as greater than one episode per week of involuntary loss of either solid or liquid stool as demonstrated by means of a baseline bowel habit and a Vaizey score of greater than 4.

• Competent and willing to fill in questionnaires and attend follow up clinics through out the study period.

Exclusion Criteria:

• Alternating bowel habit, associated with symptoms of constipation. Use of other regular or as required medications that may affect bowel function. (e.g. codeine phosphate).

• Patients with complete or partial spinal cord injuries including cauda equina syndrome.

• Active inflammatory bowel disease.

• Pregnancy

• Stoma in situ

• Psychiatric and physiological inability to comply with study protocol.

• Non english speakers (student project funding cannot cover interpreter and other costs)

(application of criteria at the discretion of the investigating doctor at initial consultation)

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

Intervention

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.
• 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

Locations

Country	Name	City	State
United Kingdom	Southampton General Hospital	Southampton	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust.	University of Southampton

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Cheetham M, Brazzelli M, Norton C, Glazener CM. Drug treatment for faecal incontinence in adults. Cochrane Database Syst Rev. 2003;(3):CD002116. Review. Update in: Cochrane Database Syst Rev. 2013;6:CD002116. — View Citation

Palmer KR, Corbett CL, Holdsworth CD. Double-blind cross-over study comparing loperamide, codeine and diphenoxylate in the treatment of chronic diarrhea. Gastroenterology. 1980 Dec;79(6):1272-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the use of imodium as tablets or syrup in the treatment of faecal incontinence in order to improve the scores of patients with faecal incontinence as seen with continence and quality of life questionnaires		2 sets of 6 weeks (3 months)	No
Secondary	To reduce to number of patients suffering from faecal incontinence		3 months	No
Secondary	Number of episodes of total, urge and passive incontinence		3 months	No
Secondary	Total number of patient incontinent days		3 months	No
Secondary	Use of pads and other medications		3 months	No
Secondary	Ability to defer defaecation		3 months	No
Secondary	Adverse effects relating to medication		3 months	Yes
Secondary	Determining the direct medical costs, direct non-medical costs, indirect non-medical costs associated with the treatment of Faecal incontinence, and cost effectiveness of treatment with syrup and tablets		3 months	No