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Opium Tincture Against Chronic Diarrhea - Patients

Primary Purpose

Chronic Diarrhea

Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Opium tincture
Placebo
Sponsored by
Asbjørn Mohr Drewes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Diarrhea focused on measuring Diarrhea, Gastrointestinal transit

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aalborg University HospitalRecruiting
  • Aarhus University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active treatment

Placebo treatment

Arm Description

Administration of opium tincture (Dropizol)

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

Outcomes

Primary Outcome Measures

Bowel movement frequency
Difference in number of spontaneous bowel movements per day between arms

Secondary Outcome Measures

Gastrointestinal transit
Difference in hours from ingestion of a wireless motility capsule to expulsion of the capsule during active and placebo treatment
Stool consistency
Rated on the Bristol Stool Form Scale (ranging from type 1 - type 7)
Pupil diameter
Measured in mm
General cognition
Evaluated using the Mini-Mental State Examination
Reaction time
Measured in milliseconds (ms) from a sound was provided and until the participant pressed a button
Short-term memory
Measured as number of digits correctly remembered after visual presentation
Gastrointestinal symptoms
Measured on the Gastrointestinal Symptom Rating Score (GSRS) questionnaire
Constipation symptoms
Measured on the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire

Full Information

First Posted
January 10, 2023
Last Updated
January 10, 2023
Sponsor
Asbjørn Mohr Drewes
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05690321
Brief Title
Opium Tincture Against Chronic Diarrhea - Patients
Official Title
Opium Tincture Against Chronic Diarrhea - Patients An Investigator Initiated, Randomized Placebo-controlled, Double-blinded, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Asbjørn Mohr Drewes
Collaborators
Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diarrhea
Keywords
Diarrhea, Gastrointestinal transit

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tina Okdahl
Phone
97663520
Email
t.okdahl@rn.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Asbjørn Mohr Drewes
Email
amd@rn.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asbjørn Mohr Drewes
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Okdahl
Phone
97663520
Email
t.okdahl@rn.dk
First Name & Middle Initial & Last Name & Degree
Asbjørn Mohr Drewes
Facility Name
Aarhus University hospital
City
Aarhus
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus Krogh
Phone
23385937
Ext
+45
Email
Klaukrog@rm.dk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data can by provided upon request
IPD Sharing Access Criteria
Researchers who provide a methodological sound proposal

Learn more about this trial

Opium Tincture Against Chronic Diarrhea - Patients

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