Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Use of N-Acetylcysteine (NAC) and Simeticone as a pre-endoscopic drink to improve mucosal visualisation during gastroscopy: A randomised controlled trial

    Summary
    EudraCT number
    		 2013-001097-24
    Trial protocol
    		 GB  
    Global end of trial date
    05 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jun 2022
    First version publication date
    01 Jun 2022
    Other versions
    Summary report(s)
    		 NICEVIS Published Paper Endoscopy International Open

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PHT/2013/01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Portsmouth Hospitals University NHS Trust
    Sponsor organisation address
    Trust Headquarters, F-Level, Queen Alexandra Hospital, Southwick Hill Road, Cosham, United Kingdom, PO6 3LY
    Public contact
    Sharon McCready, Portsmouth Hospitals University NHS Trust, +44 2392286236, research.office@porthosp.nhs.uk
    Scientific contact
    Professor Pradeep Bhandari, Portsmouth Hospitals University NHS Trust, +44 2392286000, pradeep.bhandari@porthosp.nhs.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Mar 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine if a pre-endoscopy drink of simeticone/n-acetylcysteine (a solution which will disperse bubbles and dissolve mucus) will improve views during upper gastrointestinal endoscopy (a flexible endoscopy camera examination of the gullet, stomach and duodenum). The solution will be compared to a simple water pre-endoscopy drink or no preparation.
    Protection of trial subjects
    One-off administration of the drug will be observed by the nurse pre-procedure. If a patient regurgitates or vomits any of the fluid before the procedure commences this will be noted but the procedure will be completed without further preparatory drink being given (We have not known this to be problem in our practice and the drink is very well tolerated). Participants have the right to withdraw from the study at any time for any reason. The investigator also has the right to withdraw patients from the study in the event of excessive inflammation in the upper gastrointestinal tract (this can only be identified after the endoscopy has been commenced), AEs, SAE’s, SUSAR’s, protocol violations, administrative reasons or other reasons. It is understood by all concerned that an excessive rate of withdrawals can render the study uninterpretable; therefore, unnecessary withdrawal of patients should be avoided. Should a patient decide to withdraw from the study, all efforts will be made to report the reason for withdrawal as thoroughly as possible.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jun 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 126
    Worldwide total number of subjects
    126
    EEA total number of subjects
    126
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    60
    From 65 to 84 years
    64
    85 years and over
    2

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients will be sent a study Patient Information Leaflet approximately 2-6 weeks prior to their procedure. Following this, patients will be contacted by the research team to answer any questions they have and to see if they are willing to participate. Willing patients will be approached on the day of their procedure to provide written consent

    Pre-assignment
    Screening details
    		 Patients referred for outpatient (day case) upper gastrointestinal endoscopy will be identified as possible study participants. Routine and CWT pathway patients would be considered for inclusion in the study. All referrals are processed through the endoscopy department office on a daily basis and these will be screened for possible participants.

    Period 1
    Period 1 title
    Randomisation (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Simeticone/N-acetyl cysteine pre-endoscopy drink (50ml water, 1000mg n-acetylcysteine, 60mg Simeticone
    Arm type
    		 Experimental

    Investigational medicinal product name
    Simeticone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    60mg Simeticone as part of a pre-endoscopy drink

    Investigational medicinal product name
    n-acetylcysteine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    1000mg n-acetylcysteine

    Investigational medicinal product name
    Water
    Investigational medicinal product code
    Other name
    Dihydrogen monoxide
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    50ml water as part of a pre-endoscopy drink

    Arm title
    		 Arm B
    Arm description
    		 50ml water pre-endoscopy drink
    Arm type
    		 Placebo

    Investigational medicinal product name
    Water
    Investigational medicinal product code
    Other name
    Dihydrogen monoxide
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    50ml pre-endoscopy drink

    Arm title
    		 Arm C
    Arm description
    		 no pre-endoscopy drink (current standard practice)
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Arm A Arm B Arm C
    Started
    42
    42
    42
    Completed
    42
    42
    42

    Baseline characteristics

    		 Close Top of page

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Simeticone/N-acetyl cysteine pre-endoscopy drink (50ml water, 1000mg n-acetylcysteine, 60mg Simeticone

    Reporting group title
    Arm B
    Reporting group description
    		 50ml water pre-endoscopy drink

    Reporting group title
    Arm C
    Reporting group description
    		 no pre-endoscopy drink (current standard practice)

    Primary: Mean visibility mucosal score.

    		 Close Top of page
    End point title
    		 Mean visibility mucosal score.
    End point description
    Mean overall mucosal visibility score at 4 pre-defined locations rated by four blinded assessors.
    End point type
    Primary
    End point timeframe
    Post Procedure
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    41
    40
    41
    Units: Digital photographs 4 locations
        number (not applicable)
    41
    40
    41
    Statistical analysis title
    		 Mucosal visibility scores
    Statistical analysis description
    Mean total mucosal visibility scores between groups were compared using one-way analysis of variance with Tukey’s test to detect between group differences.
    Comparison groups
    Arm A v Arm B v Arm C
    Number of subjects included in analysis
    122
    Analysis specification
    Post-hoc
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.02
         upper limit
    		 9.53
    Variability estimate
    Standard deviation
    Notes
    [1] - Mean total mucosal visibility scores between groups were compared using one-way analysis of variance with Tukey’s test to detect between group differences. In post-hoc testing the Chi-squared test was used to compare the proportion of images with inadequate visibility scores (score 3 or 4) between groups.

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Pre-Procedure to 7 days post procedure
    Adverse event reporting additional description
    Any adverse events identified were document in the patient’s medical notes and CRF. Investigator will assess AE for Seriousness. If an SAE is identified was assess for Causality, Expectedness and Intensity. An independent clinical reviewer will also assess for causality and relatedness. Follow up of participants appropriately until resolved.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 PHTRDSOP007
    Dictionary version
    1.0
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Simeticone/N-acetyl cysteine pre-endoscopy drink (50ml water, 1000mg n-acetylcysteine, 60mg Simeticone

    Reporting group title
    Arm B
    Reporting group description
    		 50ml water pre-endoscopy drink

    Reporting group title
    Arm C
    Reporting group description
    		 no pre-endoscopy drink (current standard practice)

    Serious adverse events
    		 Arm A Arm B Arm C
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 42 (2.38%)
    0 / 42 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Gastrointestinal disorders
    Laryngospasm
    Additional description: 1 participant who received water pre-procedure developed laryngospasm shortly after intubation of the oesophagus. The procedure was abandoned and the participant recovered quickly with no long-term sequelae.
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 42 (2.38%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A Arm B Arm C
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 42 (2.38%)
    0 / 42 (0.00%)
    Gastrointestinal disorders
    Abdominal pain
    Additional description: abdominal cramps and diarrhea reported post procedure.
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 42 (2.38%)
    0 / 42 (0.00%)
         occurrences all number
    0
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/2785374
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 01:29:55 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA