Opium Tincture Against Chronic Diarrhea - Patients

Chronic Diarrhea Clinical Trial

Official title:

Opium Tincture Against Chronic Diarrhea - Patients An Investigator Initiated, Randomized Placebo-controlled, Double-blinded, Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05690321
• Other study ID #: Dropizol_patients
• Secondary ID: 2020-000396-20
• Status: Completed
• Phase: Phase 2
• Start date: November 17, 2022
• Est. completion date: December 21, 2023

Study information

• Verified date: April 2024
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 21, 2023
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Diarrhea
• Diarrhea

Intervention

Drug:
• Opium tincture
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
• Placebo
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

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Asbjørn Mohr Drewes	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel movement frequency	Difference in number of spontaneous bowel movements per day between arms	From day 1 to 7
Secondary	Gastrointestinal transit	Difference in hours from ingestion of a wireless motility capsule to expulsion of the capsule during active and placebo treatment	Measurement started on day 4 of each study period until expulsion of the capsule]
Secondary	Stool consistency	Rated on the Bristol Stool Form Scale (ranging from type 1 - type 7)	From day 1 to 7 in each study period
Secondary	Pupil diameter	Measured in mm	Day 1, 4 and 7 in each study period
Secondary	General cognition	Evaluated using the Mini-Mental State Examination	Day 1, 4 and 7 in each study period
Secondary	Reaction time	Measured in milliseconds (ms) from a sound was provided and until the participant pressed a button	Day 1, 4 and 7 in each study period
Secondary	Short-term memory	Measured as number of digits correctly remembered after visual presentation	Day 1, 4 and 7 in each study period
Secondary	Gastrointestinal symptoms	Measured on the Gastrointestinal Symptom Rating Score (GSRS) questionnaire	Day 1, 4 and 7 in each study period
Secondary	Constipation symptoms	Measured on the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire	Day 1, 4 and 7 in each study period