Clinical Trial Results:
Amino acids in ileal pouch-anal anastomosis for ulcerative colitis: a randomized, double-blind placebo-controlled trial
Summary
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EudraCT number |
2014-000784-41 |
Trial protocol |
DK |
Global end of trial date |
01 Dec 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Sep 2019
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First version publication date |
21 Sep 2019
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Other versions |
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 |
2014010113
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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 |
Department of medicine and endocrinology
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Sponsor organisation address |
Palle Juul-Jensens Boulevard 99, Aarhus, Denmark, 8200
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Public contact |
Colorectal research unit, Anders Mark Christensen, Department of surgery P, Aarhus University Hospital, +45 78467712, amch@clin.au.dk
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Scientific contact |
Colorectal research unit, Anders Mark Christensen, Department of surgery P, Aarhus University Hospital, +45 78467712, amch@clin.au.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 |
13 Aug 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Dec 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Dec 2017
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To investigate the metabolic effects of intravenous amino acids given during ileal pouch-anal anastomosis surgery for ulcerative colitis.
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Protection of trial subjects |
Trial subjects were either under general anesthesia (as part of the planned operation) or received infiltration anasthesia during biopsy collection, while they were still under some influence of general anesthesia.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
06 Jan 2016
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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: 8
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Worldwide total number of subjects |
8
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EEA total number of subjects |
8
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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) |
8
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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 |
- | |||||||||
Pre-assignment
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Screening details |
Seventy-two subjects screened with only eight included. Reasons for exclusion were primarily age (>50) and an unwillingness to participate in the trial. | |||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | |||||||||
Roles blinded |
Subject | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Vaminolac | |||||||||
Arm description |
Amino acids | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Vaminolac
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Weight-adjusted: Weight (in kilograms) x 1,6 = infusion rate (ml/hour)
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Arm title
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Placebo | |||||||||
Arm description |
Saline | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Weight-adjusted: Weight (in kilograms) x 1,6 = infusion rate (ml/hour).
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Investigational medicinal product name |
Vaminolac
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Weight-adjusted: Weight (in kilograms) x 1,6 = infusion rate (ml/hour)
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Baseline characteristics reporting groups
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Reporting group title |
Vaminolac
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Reporting group description |
Amino acids | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Saline | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Change in insulin
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Placebo/saline.
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Subject analysis set title |
Change in insulin
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Amino acids.
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End points reporting groups
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Reporting group title |
Vaminolac
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Reporting group description |
Amino acids | ||
Reporting group title |
Placebo
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Reporting group description |
Saline | ||
Subject analysis set title |
Change in insulin
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Placebo/saline.
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Subject analysis set title |
Change in insulin
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Amino acids.
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End point title |
Changes in amino acid and fat rate of appearance [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Not applicable. Analyses not performed owing to too few trial subjects (futility in recruiting).
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Primary end-point not analyzed owing to premature end of trial (futility in recruiting patients). |
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Notes [2] - Not performed. [3] - Not performed. |
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No statistical analyses for this end point |
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End point title |
Change in insulin | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Change from value at one 60 minutes before intervention to 300 minutes after.
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Notes [4] - Placebo/saline [5] - Amino acids. |
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Statistical analysis title |
Wilcoxon rank sum | ||||||||||||
Comparison groups |
Change in insulin v Change in insulin
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Number of subjects included in analysis |
8
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.1 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Parameter type |
Median difference (net) | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Adverse events were ascertained from the time tracer infusions were initiated until reversal of loop ileostomy or first out-patient visit.
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Adverse event reporting additional description |
As per CT3.
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Assessment type |
Systematic | |||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CT3 | |||||||||||||||
Dictionary version |
NA
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Reporting groups
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Reporting group title |
Amino acids
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Reporting group description |
- | |||||||||||||||
Reporting group title |
Placebo (saline)
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Reporting group description |
- | |||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: It is impossible to register this on here. Six non-serious adverse events in the amino acid group and two in the placebo group. |
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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? Yes | |||||||
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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 |