Clinical Trial Results:
The role of routinely given hyoscine-N- butylbromide in colonoscopy: a double-blind, randomized, placebo-controlled, clinical trial.
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Summary
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EudraCT number |
2011-002408-34 |
Trial protocol |
FI |
Global end of trial date |
23 Oct 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Jun 2021
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First version publication date |
01 Jun 2021
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Other versions |
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Summary report(s) |
HBB study |
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 |
Nosponsor
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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 |
No sponsor
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Sponsor organisation address |
No sponsor, No sponsor, Finland,
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Public contact |
Laakso Hospital, Matti Ristikankare, +358 503279448, matti.ristikankare@kolumbus.fi
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Scientific contact |
Laakso Hospital, Matti Ristikankare, +358 503279448, matti.ristikankare@kolumbus.fi
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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 Apr 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Mar 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Oct 2014
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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 |
To find out if the routine use of hyoscine-N- butylbromide is beneficial in colonoscopy.
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Protection of trial subjects |
Normal precautions of the colonoscopic procedure. Patients with severe comorbidities or with any medications with potential interactions with hyoscine-N- butylbromide were excluded . Patients were monitored with a pulse oximetry.
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Background therapy |
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Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Mar 2012
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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 |
Finland: 150
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Worldwide total number of subjects |
150
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EEA total number of subjects |
150
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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) |
92
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From 65 to 84 years |
58
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85 years and over |
0
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Recruitment
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Recruitment details |
218 outpatients scheduled for diagnostic colonoscopy fulfilling the eligibility criteria on the basis of the referral were recruited. | |||||||||
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Pre-assignment
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Screening details |
The eligibility criteria included age between 45 and 75 years, ability to complete a questionnaire, and no history of intolerance to HBB. Patients on anticholinergic medication including tricyclic antidepressants and selective serotonin reuptake inhibitors or with a history of colonic resection, serious comorbidity | |||||||||
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Period 1
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Period 1 title |
Colonoscopy (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 |
Investigator, Subject | |||||||||
Blinding implementation details |
The patients were randomized in blocks of six by opening a sealed envelope to receive either HBB (HBB group) or saline (placebo group) i.v. The envelopes had been coded and sealed by a person not attending the trial in any other way. An injection of 10 mg (0,5 ml) HBB or an equivalent volume of saline was administered were administered and the heart rate monitored by a nurse not attending the colonoscopic procedure.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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HBB Buscopan | |||||||||
Arm description |
Patients receiving hyoscine-N- butylbromide | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
hyoscine-N- butylbromide Buscopan
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
An injection of 10 mg (0,5 ml) HBB or an equivalent volume of saline was administered over 30- 60 seconds three minutes before the introduction of the colonoscope. A supplemental dose of 10 mg HBB or saline was delivered when the tip of the colonoscope reached the cecum.
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Arm title
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Placebo | |||||||||
Arm description |
The patients receiving placebo. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
Saline
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
An injection of 10 mg (0,5 ml) HBB or an equivalent volume of saline was administered over 30- 60 seconds three minutes before the introduction of the colonoscope. A supplemental dose of 10 mg HBB or saline was delivered when the tip of the colonoscope reached the cecum.
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Baseline characteristics reporting groups
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Reporting group title |
HBB Buscopan
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Reporting group description |
Patients receiving hyoscine-N- butylbromide | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
The patients receiving placebo. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
HBB Buscopan
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Reporting group description |
Patients receiving hyoscine-N- butylbromide | ||
Reporting group title |
Placebo
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Reporting group description |
The patients receiving placebo. | ||
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End point title |
Patient tolerance | ||||||||||||
End point description |
Patient tolerance was the primary endpoint. Assuming that a difference of 15 mm in VAS evaluation is clinically relevant , the sample size was calculated to provide 95% power for detecting a difference between two groups at a 0.05 significance level.
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End point type |
Primary
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End point timeframe |
After the examination.
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Attachments |
Untitled (Filename: Figure report.docx) |
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Statistical analysis title |
Patient tolerance | ||||||||||||
Statistical analysis description |
After testing normality of distribution the continuous variables were compared with independent samples Mann Whitney U test or T test, when appropriate. The level of statistical significance was defined as p < 0.05. The results are given as mean + SEM.
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Comparison groups |
HBB Buscopan v Placebo
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Number of subjects included in analysis |
150
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
No adverse events.
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Adverse event reporting additional description |
No adverse events.
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
20
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| Frequency threshold for reporting non-serious adverse events: 1% | |||
| 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: tachycardia was not considered an advere event, |
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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 | |||
