Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study
Primary Purpose
Rectal Cancer, Ulcerative Colitis, Short Bowel Syndrome
Status
Terminated
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Loperamide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Operation for rectal cancer or ulcerative colitis an ileostomy (loop or end ileostomy within the last 7 days) OR
- ileostomy patient with contact to the stoma clinic OR
- Short bowel syndrome with a permanent ileostomy
- signed consent form
Exclusion Criteria:
- Complications associated with surgery
- Non-radical surgery
- Chemotherapy
- Poor compliance
- Other serious illness
Sites / Locations
- Odense University Hospital, Surgical Department A
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Loperamide
Placebo
Arm Description
Patients will take the drug for three days. Day 1 - uploading with the drug Day 2 - collecting output when necessary Day 3 - radiopaque marker and collection of output every two hours
Patients will take the drug for three days. Day 1 - uploading with the drug Day 2 - collecting output when necessary Day 3 - radiopaque marker and collection of output every two hours
Outcomes
Primary Outcome Measures
Output weight
Collection af output for two days to compare between the two periods
Secondary Outcome Measures
Gastrointestinal transit time
Patients swallow a pill with radiopaque markers and collect stoma output every two hours
Full Information
NCT ID
NCT02266849
First Posted
October 8, 2014
Last Updated
October 9, 2016
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02266849
Brief Title
Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study
Official Title
Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Insuficcient recruiting
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Clinical experience show limited effect of the drug Loperamide used to decrease output in stoma patients. Therefore the investigators see the need for a randomized blinded clinical trial to determine the effect of Loperamide opposite Placebo.
Loperamide will be evaluated in relation to the following parameters
Change in ileostomy output in g/day in relation to oral intake
Quantification of the change in intestinal transit time using a radiopaque marker
The patient´s own assessment on which period they received Loperamide or Placebo
Detailed Description
The aim of this study is to quantify the effect of Loperamide on ileostomy output in patients operated for rectal cancer, ulcerative colitis and in patients with short bowl syndrome. These patients are recruited through The Department of Surgery and The Department of Gastroenterology, University Hospital Odense. The effect of Loperamide will be evaluated against Placebo in relation to the following parameters:
Change in ileostomy output in g/day in relation to oral intake
Quantification of the change in intestinal transit time using a radiopaque marker
The patient´s own assessment on which period they received Loperamide or Placebo
Construction of a stoma is a frequently used part of the surgical treatment of intestinal cancer and chronic intestinal inflammation. More than 60% of patients with an ileostomy develop dehydration and loss of salts and minerals, due to an excessive stoma output. The most common method used to reduce stoma output is Imodium® ( Loperamide ). The effect has never been studied extensively, probably because it is an over the counter medicine. The treatment is relatively expensive and also subject to side effects, even if they are mild. Therefore, the investigators found it relevant to perform a clinical study to determine the effect. The results will be important for future patient treatment.
The study is a clinical blinded randomized crossover study. The study includes three types of patients. Patients operated for rectal cancer or ulcerative colitis with a temporary or permanent ileostomy, and patients with short bowel syndrome with a permanent ileostomy. The first two types of patients will be recruited through two ways.
During hospitalization in connection to their operation at The Department of Surgery, University Hospital Odense. The patients are offered inclusion into the study either before or after surgery depending upon the clinical situation. For those who consent and fulfills the inclusion criteria, the study starts up on 7th day after surgery.
Through their regular controls in the stoma clinic.
Patients with short bowel syndrome are offered inclusion through their contact with The Department of Gastroenterology, University Hospital Odense, if they meet the criteria for inclusion.
Patients will undergo to periods during the study. They will be randomized to start with either Loperamide or Placebo. Each period consists of 3 days.
Day 1 - Uploading of the drug
Day 2 - Collecting of stoma output when necessary
Day 3 - Radiopaque marker and collection of stoma output every two hours
After 7 days without medicine intake the patient starts the second period with the opposite drug.
During day 2-3 the patient will register and weigh all food and fluid intake.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Ulcerative Colitis, Short Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Loperamide
Arm Type
Active Comparator
Arm Description
Patients will take the drug for three days. Day 1 - uploading with the drug Day 2 - collecting output when necessary Day 3 - radiopaque marker and collection of output every two hours
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will take the drug for three days. Day 1 - uploading with the drug Day 2 - collecting output when necessary Day 3 - radiopaque marker and collection of output every two hours
Intervention Type
Drug
Intervention Name(s)
Loperamide
Other Intervention Name(s)
Imodium
Intervention Description
12 mg Loperamide each day for three days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
6 tablets daily for three days
Primary Outcome Measure Information:
Title
Output weight
Description
Collection af output for two days to compare between the two periods
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Gastrointestinal transit time
Description
Patients swallow a pill with radiopaque markers and collect stoma output every two hours
Time Frame
10 hours
Other Pre-specified Outcome Measures:
Title
Patient evaluation
Description
Patients evaluation on when they received Loperamide and Placebo at the end of the collecting period
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Operation for rectal cancer or ulcerative colitis an ileostomy (loop or end ileostomy within the last 7 days) OR
ileostomy patient with contact to the stoma clinic OR
Short bowel syndrome with a permanent ileostomy
signed consent form
Exclusion Criteria:
Complications associated with surgery
Non-radical surgery
Chemotherapy
Poor compliance
Other serious illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Qvist, MD, DMsc
Organizational Affiliation
Odense University Hospital, Department of Surgery A, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Odense University Hospital, Surgical Department A
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
28627732
Citation
Kristensen K, Qvist N. The Acute Effect of Loperamide on Ileostomy Output: A Randomized, Double-Blinded, Placebo-Controlled, Crossover Study. Basic Clin Pharmacol Toxicol. 2017 Dec;121(6):493-498. doi: 10.1111/bcpt.12830. Epub 2017 Jul 10.
Results Reference
derived
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Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study
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