Opium Tincture Against Chronic Diarrhea - Patients

NCT05690321 | Completed Phase 2 DMC

• 2 other identifiers: Dropizol_patients2020-000396-20
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Chronic Diarrhea

Keywords

Diarrhea; Gastrointestinal transit

Outcome Measures

Primary Outcomes (1)

• Bowel movement frequency

  Difference in number of spontaneous bowel movements per day between arms

  From day 1 to 7

Secondary Outcomes (8)

• Gastrointestinal transit

  Measurement started on day 4 of each study period until expulsion of the capsule]

• Stool consistency

  From day 1 to 7 in each study period

• Pupil diameter

  Day 1, 4 and 7 in each study period

• General cognition

  Day 1, 4 and 7 in each study period

• Reaction time

  Day 1, 4 and 7 in each study period

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

Administration of opium tincture (Dropizol)

Drug: Opium tincture

Placebo treatment

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Opium tincture DRUG

Self-administration of opium tincture (10 mg/ml) as 3x5 drops on day 1-3, 3x10 drops on days 4-6, and 1x10 drops on day 7 in each study period

Also known as: Dropizol

Active treatment

Placebo DRUG

Self-administration of placebo (10 mg/ml) as 3x5 drops on day 1-3, 3x10 drops on days 4-6, and 1x10 drops on day 7 in each study period

Placebo treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asbjørn Mohr Drewes: lead
• Aarhus University Hospital: collaborator

Study Sites (2)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Aarhus University hospital

Aarhus, Denmark

Location

Related Publications (1)

• Okdahl T, Hoyer KL, Knoph CS, Davidsen L, Larsen IM, Mark EB, Hvas CL, Krogh K, Drewes AM. Opium tincture has anti-propulsive effects in patients with chronic diarrhea: a randomized, placebo-controlled, and cross-over trial. Scand J Gastroenterol. 2024 Sep;59(9):1023-1034. doi: 10.1080/00365521.2024.2381694. Epub 2024 Jul 25.

  PMID: 39054596 DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Asbjørn Mohr Drewes

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: November 17, 2022
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Researchers who provide a methodological sound proposal

Locations

DK (2)