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Chronic DiarrheaPhase 2NCT05690321

Opium Tincture Against Chronic Diarrhea - Patients

A Phase 2 study testing Opium tincture in people with Chronic Diarrhea, run by Asbjørn Mohr Drewes at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Chronic Diarrhea
What is being tested?
Opium tincture
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
11 participants
Where
2 sitesDenmark
Study dates
17 Nov 2022to 21 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • 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.
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  • 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

Who cannot join

  • • 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
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  • 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 locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Aalborg University Hospital

    Aalborg, 9000

  • Aarhus University hospital

    Aarhus

Other trials in Denmark

About this study

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

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

Read the 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.

Being tested
Opium tincture, Placebo
Keywords
Diarrhea, Gastrointestinal transit
Medical subject headings
Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Opium tinctureDrug

    Also called Dropizol

    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

  • PlaceboDrug

    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

Study groups in NCT05690321
Study groupRoleWhat they receive
Active treatmentActive comparatorAdministration of opium tincture (Dropizol)
Receives: Drug: Opium tincture
Placebo treatmentPlacebo comparatorAdministration of placebo (identical to opium tincture in taste and appearance)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bowel movement frequency

    Difference in number of spontaneous bowel movements per day between arms

    Measured: From day 1 to 7

Secondary outcomes (8)

  1. Gastrointestinal transit

    Difference in hours from ingestion of a wireless motility capsule to expulsion of the capsule during active and placebo treatment

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

  2. Stool consistency

    Rated on the Bristol Stool Form Scale (ranging from type 1 - type 7)

    Measured: From day 1 to 7 in each study period

  3. Pupil diameter

    Measured in mm

    Measured: Day 1, 4 and 7 in each study period

  4. General cognition

    Evaluated using the Mini-Mental State Examination

    Measured: Day 1, 4 and 7 in each study period

  5. Reaction time

    Measured in milliseconds (ms) from a sound was provided and until the participant pressed a button

    Measured: Day 1, 4 and 7 in each study period

  6. Short-term memory

    Measured as number of digits correctly remembered after visual presentation

    Measured: Day 1, 4 and 7 in each study period

  7. Gastrointestinal symptoms

    Measured on the Gastrointestinal Symptom Rating Score (GSRS) questionnaire

    Measured: Day 1, 4 and 7 in each study period

  8. Constipation symptoms

    Measured on the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire

    Measured: Day 1, 4 and 7 in each study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2023
  2. Study start17 Nov 2022
  3. Primary completion21 Dec 2023
  4. Study completion21 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05690321
Sponsor's protocol ID
Dropizol_patients
Other IDs
2020-000396-20
Status last verified
Apr 2024
First submitted
10 Jan 2023
Last updated
22 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data can by provided upon request

Publications

  • 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.

    PubMed 39054596

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Opium tincture in people with Chronic Diarrhea, run by Asbjørn Mohr Drewes at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bowel movement frequency (time frame: From day 1 to 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05690321, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.

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