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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2016
• Main ID: NCT02266849
• Date of registration: 08/10/2014
• Prospective Registration: No
• Primary sponsor: Odense University Hospital
• Public title: Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study
• Scientific title: Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study
• Date of first enrolment: October 2014
• Target sample size: 12
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02266849
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Denmark

Contacts

• Name: Niels Qvist, MD, DMsc
• Affiliation: Odense University Hospital, Department of Surgery A, Denmark

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Rectal Cancer

Short Bowel Syndrome

Intervention(s)

Drug: Loperamide

Drug: Placebo

Primary Outcome(s)

Output weight [Time Frame: 2 days]

Secondary Outcome(s)

Gastrointestinal transit time [Time Frame: 10 hours]

Secondary ID(s)

s-20140081

Source(s) of Monetary Support

Please refer to primary and secondary sponsors