Study Stopped
Insuficcient recruiting
Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study
1 other identifier
interventional
12
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 8, 2014
CompletedFirst Posted
Study publicly available on registry
October 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedOctober 11, 2016
October 1, 2016
10 months
October 8, 2014
October 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Output weight
Collection af output for two days to compare between the two periods
2 days
Secondary Outcomes (1)
Gastrointestinal transit time
10 hours
Other Outcomes (1)
Patient evaluation
14 days
Study Arms (2)
Loperamide
ACTIVE COMPARATORPatients 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
Placebo
PLACEBO COMPARATORPatients 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Complications associated with surgery
- Non-radical surgery
- Chemotherapy
- Poor compliance
- Other serious illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Odense University Hospital, Surgical Department A
Odense, 5000, Denmark
Related Publications (1)
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.
PMID: 28627732DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Niels Qvist, MD, DMsc
Odense University Hospital, Department of Surgery A, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 8, 2014
First Posted
October 17, 2014
Study Start
October 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
October 11, 2016
Record last verified: 2016-10