Opium Tincture Against Chronic Diarrhea - Patients

Asbjørn Mohr Drewes

Status and phase: Completed; Phase 2

Conditions: Chronic Diarrhea

Treatments: Drug: Placebo; Drug: Opium tincture

Study type: Interventional

Funder types: Other

Identifiers

NCT05690321

Dropizol_patients

2020-000396-20 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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 expected to complete the study.
  • The investigator will ensure that fertile female participants have a negative pregnancy test before each treatment visit and use contraception during the entity of the study.
  • Specific underlying pathophysiology has been identified, but targeted treatment (e.g. antibiotics or bile acid sequestrants) and treatment with loperamide has failed.

OR

• No specific underlying pathophysiology has been identified and treatment with loperamide 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 criteria

• • Known allergy towards pharmaceutical compounds similar to Dropizol.

  • Participation in other studies within 14 days of first visit (1 year if opioids involved).
  • Expected need of medical/surgical treatment during the study
  • History of psychiatric illness (e.g. mental retardation, schizophrenia, major depression)
  • History of substance abuse (e.g. alcohol, THC, benzodiazepine, central stimulants and/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 ongoing exacerbation)
  • Known cor pulmonale
  • Female participants that are lactating
  • Medicine known to affect gastrointestinal motility must not be initiated during the entity of the study
  • Treatment with opium tincture during the last month

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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11 participants in 2 patient groups, including a placebo group

Active treatment

Active Comparator group

Description:

Administration of opium tincture (Dropizol)

Treatment:

Drug: Opium tincture

Placebo treatment

Placebo Comparator group

Description:

Administration of placebo (identical to opium tincture in taste and appearance)

Treatment:

Drug: Placebo