Methylnaltrexone for the Treatment of Opioid drug Induced Constipation (MOTION Study)

Phase 1

Conditions: Opioid Induced Constipation
MedDRA version: 17.1Level: PTClassification code 10010774Term: ConstipationSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Registration Number: EUCTR2014-004687-37-GB

Lead Sponsor: Imperial College Healthcare NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 84

Inclusion Criteria

• Males and females = 18 years of age
• Following ICU admission, sedated with opioids and requiring invasive ventilator support
• Scheduled for continuous infusion/administration of opioid analgesics for at least a further 24 hours
• Constipated (not opened bowels for a minimum 48 hours following ICU admission)
• Access for enteral administration of medications and nasal-gastric tube feeds
• Initiation of nasogastric tube feeds
• Patient weight of 38-114kg (this allows pre preparation of drug with either 8mg or 12mg)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

•Known to be pregnant
•Patients with end stage renal failure requiring dialysis on admission
•Diarrhoea on admission
• Abdominal surgery within 8 weeks prior to ICU admission
• Presence of Ileostomy or colostomy
• Mechanical gastrointestinal obstruction
• Suspected Acute surgical abdomen
• History of Crohn's disease or ulcerative colitis
• On Palliative care or not expected to survive more than 12 hours
• Severe chronic hepatic impairment (Child Pugh Class C)
• Suspected hepatic encephalopathy
• 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 MOTION

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of methylnaltrexone in producing laxation in patients sedated with opioid infusions.;Secondary Objective: 1.To assess if the use of methylnaltrexone leads to increased opioid requirements through CNS penetration and antagonism<br><br>2.To assess if there are additional benefits from preventing constipation such as reduced gastric stasis, improved enteral feeding, and a reduction in infection<br><br>3.To assess the safety and side effect profile of intravenous methylnaltrexone in ICU patients<br><br>4.Blood will further analysed and stored for:<br>• Cytokine levels<br>• Leucocyte function assays<br>• Metabolic profiles;Primary end point(s): Time to rescue-free opening bowels following randomisation. Significant bowel opening is defined as an estimate of stool volume of greater than 100nls by the attending nurse.;Timepoint(s) of evaluation of this end point: Up to 28 days after randomisation.

Secondary Outcome Measures