Loperamide Concentrations in IF

• Research type

  Research Study

• Full title

  High Dose Loperamide in Patients with Intestinal Failure (IF): Plasma Concentration and Electrocardiogram(ECG) Changes

• IRAS ID

  260617

• Contact name

  Stephen Lewis

• Contact email

  stephenlewis1@nhs.net

• Sponsor organisation

  Dr C Rollinson

• Eudract number

  2019-003172-40

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Patients with intestinal failure due to short bowel syndrome (SBS-IF) often require high doses (above the maximum licensed dose) of loperamide to control stoma output and thus enable adequate nutrient absorption and prevent water and electrolyte loss. The assumption has always been that these patients have poor drug absorption and limited capacity for enterohepatic recirculation. In high doses loperamide is potentially toxic. There have been reports of cardiac toxicity in patients and opiate abusers who have ingested very high doses of loperamide in order to obtain euphoric effects.
  We aim to do two clinical studies. The first will be a pilot pharmacokinetic(PK) study of loperamide in patients with SBS-IF and healthy controls. The second will be a pharmacokinetic/pharmacodynamic (PK/PD) study to measure the concentrations of loperamide (and its metabolites) in plasma and saliva in patients with SBS-IF and to determine whether any correlation exists with patient clinical characteristics (e.g. stoma output) or specific ECG parameters (e.g. QT interval) suggesting toxicity. We will use data from the first study to inform the exact design (optimal sampling times) for the second study.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  19/SW/0172

• Date of REC Opinion

  19 Nov 2019

• REC opinion

  Further Information Favourable Opinion