Clinical Trial Results:
Mode of action of Moviprep:impact on distribution of intestinal fluid and colonic microbiota
Summary
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EudraCT number |
2010-021879-85 |
Trial protocol |
GB |
Global end of trial date |
17 Apr 2012
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Jan 2019
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First version publication date |
05 Jan 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 |
10050
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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 |
University of Nottingham
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Sponsor organisation address |
Jubilee Campus Wollaton Road , Nottingham , United Kingdom, NG8 1BB
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Public contact |
Professor Robin Spiller
Nottingham Digestive Diseases Biomedical Research Unit
Nottingham Digestiv, Nottingham Digestive Diseases Biomedical Research Unit, 0115 8231032, robin.spiller@nottingham.ac.uk
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Scientific contact |
Professor Robin Spiller
Nottingham Digestive Diseases Biomedical Research Unit
Nottingham Digestiv, Nottingham Digestive Diseases Biomedical Research Unit, 0115 8231032, robin.spiller@nottingham.ac.uk
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Sponsor organisation name |
University of Nottingham
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Sponsor organisation address |
Jubilee Campus Wollaton Road , Nottingham , United Kingdom, NG8 1BB
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Public contact |
Emma Bradley, Nottingham Digestive Diseases Biomedical Research Unit, 0115 823090, emma.bradley@nottingham.ac.uk
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Scientific contact |
Professor Robin Spiller, Nottingham Digestive Diseases Biomedical Research Unit, 0115 8231032, robin.spiller@nottingham.ac.uk
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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 |
17 Apr 2012
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
17 Apr 2012
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Apr 2012
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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 |
Patients often have to take osmotic laxatives to prepare the colon for colonoscopy or barium enema. We are interested in how these work and whether taking the dose all at once or in divided doses will affect the water distribution in the small bowel.
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Protection of trial subjects |
The National Research Ethics Service (NREC) ethics approval (version 2.0 dated 20th
August 2010), approval number 10/H0906/50, was obtained on 29th August 2010.
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Background therapy |
none all healthy volunteers | ||
Evidence for comparator |
Comparator was same preparation given in divided or single dose | ||
Actual start date of recruitment |
08 Sep 2010
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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 |
United Kingdom: 24
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Worldwide total number of subjects |
24
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EEA total number of subjects |
24
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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) |
24
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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 |
by public advert | |||||||||||||||
Pre-assignment
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Screening details |
Bowel symptom questionnaire to exclude functional bowel disorders | |||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
24 | |||||||||||||||
Number of subjects completed |
24 | |||||||||||||||
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 |
Not blinded | |||||||||||||||
Blinding implementation details |
Study compared 2l with 1l in divided doses given on two consecutive days
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group1 | |||||||||||||||
Arm description |
Consumed 1l litre moviprep at 1300h on day 1 and repeated on day 2 | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Moviprep
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
1litre made by adding sachet A and B together in 1 litre of tap water
Sachet A contains the following active substances:
Macrogol 3350
Sodium sulfate anhydrous
Sodium chloride
Potassium chloride
100 g
7.500 g
2.691 g
1.015 g
Sachet B contains the following active substances:
Ascorbic acid
Sodium ascorbate
4.700 g
5.900 g
The concentration of electrolyte ions when both sachets are made up to one litre of solution is as follows:
Sodium
Sulfate
Chloride
Potassium
Ascorbate
181.6 mmol/L (of which not more than 56.2 mmol is absorbable)
52.8 mmol/L
59.8 mmol/L
14.2 mmol/L
29.8 mmol/L
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Arm title
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group 2 | |||||||||||||||
Arm description |
2l moviprep | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Moviprep
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
2litre made by adding 2sachet A and 2B together in 2 litre of tap water
Sachet A contains the following active substances:
Macrogol 3350
Sodium sulfate anhydrous
Sodium chloride
Potassium chloride
100 g
7.500 g
2.691 g
1.015 g
Sachet B contains the following active substances:
Ascorbic acid
Sodium ascorbate
4.700 g
5.900 g
The concentration of electrolyte ions when both sachets are made up to one litre of solution is as follows:
Sodium
Sulfate
Chloride
Potassium
Ascorbate
181.6 mmol/L (of which not more than 56.2 mmol is absorbable)
52.8 mmol/L
59.8 mmol/L
14.2 mmol/L
29.8 mmol/L
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End points reporting groups
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Reporting group title |
Group1
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Reporting group description |
Consumed 1l litre moviprep at 1300h on day 1 and repeated on day 2 | ||
Reporting group title |
group 2
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Reporting group description |
2l moviprep | ||
Subject analysis set title |
all
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
all completing study
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End point title |
small bowel water content | ||||||||||||||||
End point description |
AUC o-4 hours after ingestion
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End point type |
Primary
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End point timeframe |
0-4hours after ingestion
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Notes [1] - i failed to complete study |
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Statistical analysis title |
statistics | ||||||||||||||||
Statistical analysis description |
ANOVA
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Comparison groups |
Group1 v group 2
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Number of subjects included in analysis |
24
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Analysis specification |
Pre-specified
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Analysis type |
superiority [2] | ||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||
Method |
ANOVA | ||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||
Point estimate |
272
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Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
0 | ||||||||||||||||
upper limit |
612 | ||||||||||||||||
Variability estimate |
Standard deviation
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Dispersion value |
170
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Notes [2] - ANOVA for effect of time and treatment |
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Adverse events information
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Timeframe for reporting adverse events |
study days
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Adverse event reporting additional description |
mild abdominal discomfort after moviprep ingestion
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Assessment type |
Non-systematic | |||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||
Dictionary version |
15
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Reporting groups
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Reporting group title |
group1
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Reporting group description |
- | |||||||||||||||||||||
Reporting group title |
group2
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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 |