Clinical Trial Results:
Clinical trial to evaluate the efficacy and safety of oral Transidose in patients suffering from constipation.
Summary
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EudraCT number |
2013-002900-15 |
Trial protocol |
DE |
Global end of trial date |
31 Mar 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Jun 2020
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First version publication date |
28 Jun 2020
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Other versions |
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Summary report(s) |
Statistical Report Transidose final |
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 |
Transidose-GE_01/2013
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Salsarulo Pharma
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Sponsor organisation address |
8 rue de l'Est, Boulogne-Billancourt, France, 92100
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Public contact |
Gilles Salsarulo, Salsarulo Pharma, 0033 618920891, gilles.salsarulo@salsapharma.com
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Scientific contact |
Gilles Salsarulo, Salsarulo Pharma, 0033 618920891, gilles.salsarulo@salsapharma.com
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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 |
07 Sep 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Mar 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Mar 2016
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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 |
Evaluation of the efficacy and safety of Transidose p.o.
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Protection of trial subjects |
If diarrhea develops the dosage has to be reduced. If diarrhea persists, the treatment with Transidose has to be discontinued.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Mar 2014
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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 |
Germany: 10
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Worldwide total number of subjects |
10
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EEA total number of subjects |
10
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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 |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Candidates for the participation in this monocentric clinical trial are male and female patients as of 18 years of age, suffering from constipation with associated symptoms. Indication for inclusion in the study are rare bowel movements (stool frequency less than three times a week) and the fulfillment of the Rome III criteria. Moreover, a colon | ||||||||||
Pre-assignment
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Screening details |
The study is introduced by a wash-out period of one week. During this period, patients should not use laxatives. Afterwards the two-week active treatment period follows. The daily dosage during treatment will range between 10 g and 20 g TRANSIDOSE (1 to 2 sachets corresponding to 3.5 to 7 g lactulose), taken orally as single dose in the evening | ||||||||||
Period 1
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Period 1 title |
Period 1 - Wash-out
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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Transidose | ||||||||||
Arm description |
The daily dosage during treatment will range between 10 g and 20 g TRANSIDOSE (1 to 2 sachets corresponding to 3.5 to 7 g lactulose), taken orally as single dose in the evening but not shortly before bedtime. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Transidose
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral paste in sachet
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Routes of administration |
Oral use
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Dosage and administration details |
The daily dosage during treatment will range between 10 g and 20 g TRANSIDOSE (1 to 2 sachets corresponding to 3.5 to 7 g lactulose), taken
orally as single dose in the evening but not shortly before bedtime.
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Period 2
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Period 2 title |
Period 2 - Active arm
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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Transidose | ||||||||||
Arm description |
The daily dosage during treatment will range between 10 g and 20 g TRANSIDOSE (1 to 2 sachets corresponding to 3.5 to 7 g lactulose), taken orally as single dose in the evening but not shortly before bedtime. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Transidose
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral paste in sachet
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Routes of administration |
Oral use
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Dosage and administration details |
The daily dosage during treatment will range between 10 g and 20 g TRANSIDOSE (1 to 2 sachets corresponding to 3.5 to 7 g lactulose), taken
orally as single dose in the evening but not shortly before bedtime.
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Baseline characteristics reporting groups
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Reporting group title |
Period 1 - Wash-out
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Transidose
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Reporting group description |
The daily dosage during treatment will range between 10 g and 20 g TRANSIDOSE (1 to 2 sachets corresponding to 3.5 to 7 g lactulose), taken orally as single dose in the evening but not shortly before bedtime. | ||
Reporting group title |
Transidose
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Reporting group description |
The daily dosage during treatment will range between 10 g and 20 g TRANSIDOSE (1 to 2 sachets corresponding to 3.5 to 7 g lactulose), taken orally as single dose in the evening but not shortly before bedtime. |
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End point title |
Difference of number of spontaneaous evacuation per week | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
After 2 weeks of treatment
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Statistical analysis title |
Wilcoxon test | ||||||||||||
Comparison groups |
Transidose v Transidose
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Number of subjects included in analysis |
18
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
ANOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
- | ||||||||||||
upper limit |
- | ||||||||||||
Variability estimate |
Standard deviation
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End point title |
Patient's judgement of efficacy | ||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
After 2 weeks of treatment
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No statistical analyses for this end point |
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End point title |
Bristol Stool Forms Scale | |||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
After 2 weeks of treatment
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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 |
At treatment start, after 1 week of treatment and at final visit (after 2 weeks of treatment)
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.0
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Reporting groups
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Reporting group title |
AE reporting group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |