Clinical Trial Results:
Opium tincture against chronic diarrhea - Patients: An investigator initiated, randomized placebo-controlled, clinical trial
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Summary
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EudraCT number |
2020-000396-20 |
Trial protocol |
DK |
Global end of trial date |
21 Dec 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Sep 2024
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First version publication date |
04 Sep 2024
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
Dropizol_2020
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05690321 | ||
WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Aalborg University Hospital
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Sponsor organisation address |
Mølleparkvej 4, Aalborg, Denmark, 9000
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Public contact |
Tina Okdahl , Mech-Sense, Aalborg University Hospital, +45 97663520, t.okdahl@rn.dk
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Scientific contact |
Tina Okdahl , Mech-Sense, Aalborg University Hospital, +45 97663520, t.okdahl@rn.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Feb 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
21 Dec 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Dec 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Main objective of the trial is to describe the efficacy and safety of opium tincture (Dropizol®, Pharmanovia A/S, Denmark) against chronic diarrhea.
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Protection of trial subjects |
Subjects were instructed to report all experienced side effects in a diary, which was monitored throughout the study
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Jan 2023
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 11
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Worldwide total number of subjects |
11
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EEA total number of subjects |
11
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
10
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment was initiated in January 2023 and was finalized in December 2023 | |||||||||
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Pre-assignment
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Screening details |
A medical doctor screened all subjects according to the inclusion and exclusion criteria | |||||||||
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Pre-assignment period milestones
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Number of subjects started |
11 | |||||||||
Number of subjects completed |
11 | |||||||||
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Period 1
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Period 1 title |
Intervention (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | |||||||||
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Opium tincture | |||||||||
Arm description |
Active intervention | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Opium tincture
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral drops, liquid
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Routes of administration |
Oral use
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Dosage and administration details |
The treatment was divided into two phases: up-titration (3 × 5 drops on days 1–3) and end-titration (3 × 10 drops on days 4–6 and 2 × 10 drops on day 7)
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Arm title
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Placebo | |||||||||
Arm description |
Placebo intervention | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo drops
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral drops, liquid
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Routes of administration |
Oral use
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Dosage and administration details |
The treatment was divided into two phases: up-titration (3 × 5 drops on days 1–3) and end-titration (3 × 10 drops on days 4–6 and 2 × 10 drops on day 7)
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Baseline characteristics reporting groups
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Reporting group title |
Intervention
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Opium tincture
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Reporting group description |
Active intervention | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo intervention | ||
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End point title |
Mean number of daily bowel movements | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Comparison of mean number of bowel movements per day during active and placebo treatment
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Statistical analysis title |
Bowel movement frequency between treatments | ||||||||||||
Statistical analysis description |
Bowel movement frequency between treatments was compared using a repeated mixed model with days and treatments (place/opium tincture) as factors
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Comparison groups |
Opium tincture v Placebo
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Number of subjects included in analysis |
22
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.002 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events were collected from the time of inclusion to 5 days after study end
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Adverse event reporting additional description |
Adverse events were noted by subjects in a diary, and study personel also asked about adverse events at vistis and follow-up calls
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
None | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
During active treatment
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
During placebo treatment
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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17 Nov 2022 |
The study design was changed from a parallel design to a cross-over design |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
