Opium Tincture Against Chronic Diarrhea - Patients

Last updated: April 19, 2024
Sponsor: Asbjørn Mohr Drewes
Overall Status: Completed

Phase

2

Condition

Lactose Intolerance

Chronic Diarrhea

Stomach Discomfort

Treatment

Placebo

Opium tincture

Clinical Study ID

NCT05690321
Dropizol_patients
2020-000396-20
  • Ages > 20
  • All Genders

Study Summary

The purpose of this study is to investigate the mechanistic anti-propulsive effects of opium tincture on the gastrointestinal tract of a cohort of patients with chronic diarrhea

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Signed informed consent before any study specific procedures
  • Able to read and understand Danish
  • Male or female with an age of 20 years or more
  • The researcher believes that the participant understands what the study entails,are capable of following instructions, can attend when needed, and are expectedto complete the study.
  • The investigator will ensure that fertile female participants have a negativepregnancy test before each treatment visit and use contraception during theentity of the study.
  • Specific underlying pathophysiology has been identified, but targeted treatment (e.g. antibiotics or bile acid sequestrants) and treatment with loperamide hasfailed. OR
  • No specific underlying pathophysiology has been identified and treatment withloperamide has failed.
  • At least 6 months post-surgery in the gastrointestinal tract
  • No sign of cancer at standard clinical follow-up
  • Chronic diarrhea defined as at least 3 daily bowel movements for the last week

Exclusion

Exclusion Criteria:

  • • Known allergy towards pharmaceutical compounds similar to Dropizol.
  • Participation in other studies within 14 days of first visit (1 year if opioidsinvolved).
  • Expected need of medical/surgical treatment during the study
  • History of psychiatric illness (e.g. mental retardation, schizophrenia, majordepression)
  • History of substance abuse (e.g. alcohol, THC, benzodiazepine, central stimulantsand/or opioids)
  • Family history of substance abuse
  • Known major stenosis of the intestines
  • Known severe decreased renal function (defined as eGFR below 30)
  • Known severe decreased hepatic function (defined as Child-Pugh class B or higher)
  • Treatment with MAO- inhibitors during the entity of the study
  • Severe COPD or acute severe asthma (defined as FEV1 below 50 % or acute ongoingexacerbation)
  • Known cor pulmonale
  • Female participants that are lactating
  • Medicine known to affect gastrointestinal motility must not be initiated duringthe entity of the study
  • Treatment with opium tincture during the last month

Study Design

Total Participants: 11
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 17, 2022
Estimated Completion Date:
December 21, 2023

Study Description

Opium tincture is used a symptomatic drug against chronic diarrhea even though no clinical studies have investigated the effect on gastrointestinal function. With this randomized, double-blind, placebo-controlled cross-over trial in 16 patients with chronic diarrhea, we wish to provide evidence-based insights into the effects of opium tincture on gastrointestinal function. Additionally, effects on the central nervous system will be investigated a tertiary aim.

Connect with a study center

  • Aalborg University Hospital

    Aalborg, 9000
    Denmark

    Site Not Available

  • Aarhus University hospital

    Aarhus,
    Denmark

    Site Not Available

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