Imodium Syrup Versus Imodium Tablets for Faecal Incontinence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University Hospital Southampton NHS Foundation Trust..
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University of Southampton
Information provided by:
University Hospital Southampton NHS Foundation Trust.
ClinicalTrials.gov Identifier:
NCT00933465
First received: July 3, 2009
Last updated: July 6, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Fecal Incontinence
Drug: Imodium (Loperamide Hydrochloride) syrup
Drug: Imodium (Loperamide hydrochloride) tablets
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Blinded Randomised Cross-Over Study of Imodium Tablets Versus Imodium Syrup for the Treatment of Faecal Incontinence

Resource links provided by NLM:


Further study details as provided by University Hospital Southampton NHS Foundation Trust.:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 sets of 6 weeks (3 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To reduce to number of patients suffering from faecal incontinence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of episodes of total, urge and passive incontinence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Total number of patient incontinent days [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Use of pads and other medications [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Ability to defer defaecation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Adverse effects relating to medication [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: October 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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

Experimental: 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
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


  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933465

Contacts
Contact: Karen Nugent, MA MSmedFRCS 0044 (0)2380 796145 k.p.nugent@soton.ac.uk

Locations
United Kingdom
Southampton General Hospital Not yet recruiting
Southampton, Hampshire, United Kingdom, so16 6YD
Principal Investigator: Karen Nugent, MA MSmedFRCS         
Sub-Investigator: Graham Broadley, med student         
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust.
University of Southampton
Investigators
Principal Investigator: Karen Nugent, MA MSmedFRCS University Hospital Southampton NHS Foundation Trust.
  More Information

Publications:
Responsible Party: Miss Karen Nugent, Southampton University hospital NHS trust
ClinicalTrials.gov Identifier: NCT00933465     History of Changes
Other Study ID Numbers: RHMMED0874, eudraCT number; 2009-013776-49
Study First Received: July 3, 2009
Last Updated: July 6, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service

Keywords provided by University Hospital Southampton NHS Foundation Trust.:
Fecal incontinence

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Loperamide
Antidiarrheals
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 10, 2014