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Trial record 10 of 34017 for:    Placebo AND placebo effect

Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study

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ClinicalTrials.gov Identifier: NCT02266849
Recruitment Status : Terminated (Insuficcient recruiting)
First Posted : October 17, 2014
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
Niels Qvist, Odense University Hospital

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

Condition or disease Intervention/treatment Phase
Rectal Cancer Ulcerative Colitis Short Bowel Syndrome Drug: Loperamide Drug: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study
Study Start Date : October 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Loperamide

Arm Intervention/treatment
Active Comparator: Loperamide
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
Drug: Loperamide
12 mg Loperamide each day for three days
Other Name: Imodium

Placebo Comparator: Placebo
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
Drug: Placebo
6 tablets daily for three days




Primary Outcome Measures :
  1. Output weight [ Time Frame: 2 days ]
    Collection af output for two days to compare between the two periods


Secondary Outcome Measures :
  1. Gastrointestinal transit time [ Time Frame: 10 hours ]
    Patients swallow a pill with radiopaque markers and collect stoma output every two hours


Other Outcome Measures:
  1. Patient evaluation [ Time Frame: 14 days ]
    Patients evaluation on when they received Loperamide and Placebo at the end of the collecting period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266849


Locations
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Denmark
Odense University Hospital, Surgical Department A
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
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Study Director: Niels Qvist, MD, DMsc Odense University Hospital, Department of Surgery A, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Niels Qvist, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02266849     History of Changes
Other Study ID Numbers: s-20140081
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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Colitis, Ulcerative
Short Bowel Syndrome
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Colitis
Gastroenteritis
Colonic Diseases
Inflammatory Bowel Diseases
Malabsorption Syndromes
Postoperative Complications
Pathologic Processes
Loperamide
Antidiarrheals
Gastrointestinal Agents