Methylnaltrexone for the treatment of opioid induced constipatio

Phase 4

Completed

• Conditions: Topic: Critical care; Subtopic: Critical care; Disease: All Critical care; Digestive System

• Registration Number: ISRCTN75305839
• Lead Sponsor: Imperial College London

Brief Summary

2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27412108 protocol 2016 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/27573565 post-hoc analysis (added 23/07/2019) 2020 Results article in https://doi.org/10.1007/s00134-019-05913-6 (added 25/04/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-25
• Study Completion: 2018-02-28
• Last Update Posted: 8 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Males and females at least 18 years of age
2. Following ICU admission, sedated with opioids and requiring invasive ventilator support
3. Scheduled for continuous infusion/administration of opioid analgesics for at least a further 24 hours
4. Constipated (not opened bowels for a minimum 48 hours following ICU admission)
5. Access for enteral administration of medications and nasogastric tube feeds
6. Initiation of nasogastric tube feeds
7. Patient weight of 38-114 kg (this allows pre preparation of drug with either 8 mg or 12 mg)

Exclusion Criteria

1. Known to be pregnant
2. Patients with end stage renal failure requiring dialysis on admission
3. Diarrhoea on admission
4. Abdominal surgery within 8 weeks prior to ICU admission
5. Presence of Ileostomy or colostomy
6. Mechanical gastrointestinal obstruction
7. Suspected acute surgical abdomen
8. History of Crohn's disease or ulcerative colitis
9. On palliative care or not expected to survive more than 12 hours
10. Severe chronic hepatic impairment (Child Pugh Class C)
11. Suspected hepatic encephalopathy
12. Known to have received another IMP within 30 days or currently in another interventional trial that might interact with the study drug or previously enrolled into MOTIO

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to significant rescue-free laxation (stool volume of greater than 100 ml) following randomisation; Timepoint(s): Daily