Clinical Trial Results:
Opium tincture against chronic diarrhea - Healthy:
An investigator initiated, randomized placebo-controlled, double-blinded, cross-over, clinical trial
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Summary
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EudraCT number |
2020-004875-41 |
Trial protocol |
DK |
Global end of trial date |
05 Jun 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Oct 2022
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First version publication date |
28 Oct 2022
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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_healthy_2020
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Mech-Sense, 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, 97663520 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 |
11 Jul 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
05 Jun 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Jun 2022
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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 (R), 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 |
01 Oct 2020
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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: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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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) |
18
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment was initiated in 2020 and was finalized in 2022 | |||||||||
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Pre-assignment
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Screening details |
A medical doctor screened al subjects according to the inclusion and exclusion criteria | |||||||||
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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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Active treatment | |||||||||
Arm description |
Subjects receiving active treatment (opium tincture) | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Opium Tincture
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Investigational medicinal product code |
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Other name |
Dropizol
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Pharmaceutical forms |
Oral drops
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Routes of administration |
Oral use
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Dosage and administration details |
3x5 drops on day 1, 3x10 drops on day 2-9
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Arm title
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Placebo | |||||||||
Arm description |
Subjects receiving placebo | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral drops
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Routes of administration |
Oral use
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Dosage and administration details |
3*5 drops on day 1, 3x10 drops on day 2-9
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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 |
Active treatment
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Reporting group description |
Subjects receiving active treatment (opium tincture) | ||
Reporting group title |
Placebo
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Reporting group description |
Subjects receiving placebo | ||
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End point title |
Change in colonic transit time | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Change in transit time between during active and placebo treatment
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Statistical analysis title |
Colonc transit - mixed model | ||||||||||||
Statistical analysis description |
Data were compared using a repeated measures mixed model with treatment (placebo, opium tincture) and segments (stomach, small bowel, colon, and whole gut) and as factors. In cases of significant findings, a subsequent Bonferroni-corrected post hoc analysis accounting for multiple comparisons was performed to investigate which segments differed between treatments.
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Comparison groups |
Placebo v Active treatment
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Confidence interval |
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95% | ||||||||||||
sides |
2-sided
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lower limit |
- | ||||||||||||
upper limit |
- | ||||||||||||
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End point title |
Daily bowel movements | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Subjects reported daily bowel movements during the entire study period
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| No statistical analyses for this end point | |||||||||||||
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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 |
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 intervention
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Reporting group description |
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Reporting group title |
During placebo
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
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 | |||
