Imodium Syrup Versus Imodium Tablets for Faecal Incontinence

NCT00933465 | Withdrawn Phase 4

• 2 other identifiers: RHMMED0874eudraCT number; 2009-013776-49
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Fecal incontinence

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (7)

• To reduce to number of patients suffering from faecal incontinence

  3 months

• Number of episodes of total, urge and passive incontinence

  3 months

• Total number of patient incontinent days

  3 months

• Use of pads and other medications

  3 months

• Ability to defer defaecation

  3 months

Study Arms (2)

tablets first followed by syrup

EXPERIMENTAL

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

Drug: Imodium (Loperamide Hydrochloride) syrup; Drug: Imodium (Loperamide hydrochloride) tablets

Syrup first followed by tablets

EXPERIMENTAL

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

Drug: Imodium (Loperamide Hydrochloride) syrup; Drug: Imodium (Loperamide hydrochloride) tablets

Interventions

Imodium (Loperamide Hydrochloride) syrup 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.

Syrup first followed by tablets; tablets first followed by syrup

Imodium (Loperamide hydrochloride) tablets 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; tablets first followed by syrup

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• University of Southampton: collaborator

Study Sites (1)

Southampton General Hospital

Southampton, Hampshire, so16 6YD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 7002706 BACKGROUND

• 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.

  PMID: 12917921 BACKGROUND

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Loperamide; Tablets

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Karen Nugent, MA MSmedFRCS

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 3, 2009
• First Posted: July 7, 2009
• Study Start: October 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

GB (1)