ACTRN12614000180617
Terminated
Phase 3
A Double-blind Randomised, Placebo-controlled Trial to Assess the Efficacy of Loperamide versus Placebo as Post-operative Prevention of High Output Ileostomy Losses in Patients with New Loop Ileostomy.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hunter New England Local Health District
- Enrollment
- 86
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent
- •\-All adult (\>18 years) patients undergoing elective or semi\-urgent booked operations involving a loop ileostomy at the participating hospitals.
- •\-Must have passed flatus post\-operatively, tolerating diet and no signs and symptoms of ileus.
Exclusion Criteria
- •\-Refuse or are unable to give written informed consent to participate in the study, or
- •\-Have a known allergy or adverse drug reaction to loperamide
- •\-Pregnant or lactating females
- •\-Have a eGFR less than 60ml/min/1\.73m3 pre\-operatively
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
A Double-Blind Randomised Placebo-Controlled Trial of Vitamin D Supplements for Pregnant Women with Low Levels of Vitamin D in Early Pregnancy - MAVIDOSOsteoporosisMedDRA version: 9.1Level: LLTClassification code 10005991Term: Bone mass decreasedEUCTR2007-001716-23-GBSouthampton University Hospitals NHS Trust1,000
Active, not recruiting
Phase 1
A study to compare the use of ferric carboxymaltose with placebo in patients with acute heart failure and iron deficiencyAcute heart failure with iron deficiencyMedDRA version: 20.0Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: LLTClassification code 10000803Term: Acute heart failureSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10022970Term: Iron deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2016-001467-36-PLVifor (International) Inc.650
Active, not recruiting
Phase 1
A study to compare the use of ferric carboxymaltose with placebo in patients with acute heart failure and iron deficiencyAcute heart failure with iron deficiencyMedDRA version: 20.0Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: LLTClassification code 10000803Term: Acute heart failureSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10022970Term: Iron deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2016-001467-36-ESVifor (International) Inc.1,110
Active, not recruiting
Phase 1
A study to compare the use of ferric carboxymaltose with placebo in patients with acute heart failure and iron deficiencyEUCTR2016-001467-36-NLVifor (International) Inc.1,110
Active, not recruiting
Phase 1
A study to compare the use of ferric carboxymaltose with placebo in patients with acute heart failure and iron deficiencyAcute heart failure with iron deficiencyMedDRA version: 20.0Level: LLTClassification code 10000803Term: Acute heart failureSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10022970Term: Iron deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2016-001467-36-ITVIFOR (INTERNATIONAL) INC.1,110