Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| eudraCT number; 2009-013776-49 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Southampton | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
(application of criteria at the discretion of the investigating doctor at initial consultation)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karen Nugent, MA MSmedFRCS | University Hospital Southampton NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southampton General Hospital | Southampton | Hampshire | so16 6YD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7002706 | Background | 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. | |
| 12917921 | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008139 | Loperamide |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
|
| 3 months |
| Use of pads and other medications | 3 months |
| Ability to defer defaecation | 3 months |
| Adverse effects relating to medication | 3 months |
| 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 |
| D004364 |
| Pharmaceutical Preparations |