Imodium Syrup Versus Imodium Tablets for Faecal Incontinence

NCT ID: NCT00933465

Last Updated: 2014-11-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

tablets first followed by syrup

first 6 weeks of study using tablets, then followed by assessment, and then the next 6 weeks using syrup, followed by assessment

Group Type: EXPERIMENTAL

Imodium (Loperamide Hydrochloride) syrup

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Syrup first followed by tablets

first 6 weeks of study using syrup, then followed by assessment, and then the next 6 weeks using tablets, followed by assessment

Group Type: EXPERIMENTAL

Imodium (Loperamide Hydrochloride) syrup

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southampton

OTHER

Sponsor Role: collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Southampton University hospital NHS trust

Principal Investigators

Karen Nugent, MA MSmedFRCS

Role: PRINCIPAL_INVESTIGATOR

University Hospital Southampton NHS Foundation Trust

Locations

Southampton General Hospital

Southampton, Hampshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 7002706 (View on PubMed)

Cheetham M, Brazzelli M, Norton C, Glazener CM. Drug treatment for faecal incontinence in adults. Cochrane Database Syst Rev. 2003;(3):CD002116. doi: 10.1002/14651858.CD002116.

Reference Type: BACKGROUND

PMID: 12917921 (View on PubMed)

Other Identifiers

eudraCT number; 2009-013776-49

Identifier Type: -

Identifier Source: secondary_id

RHMMED0874

Identifier Type: -

Identifier Source: org_study_id