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    Clinical Trial Results:
    EFICACY AND TOLERABILITY OF TWO REDUCED VOLUME PRODUCTS FOR COLORRECTAL CANCER SCREENING COLONOSCOPY: A COMPARATIVE, PARALLEL RANDOMIZED CLINICAL TRIAL. LOWOL STUDY.

    Summary
    EudraCT number
    		 2019-003186-18
    Trial protocol
    		 ES  
    Global end of trial date
    11 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jun 2026
    First version publication date
    11 Jun 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LOWOL-19
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04297423
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundació Clínic per a la Recerca Biomèdica
    Sponsor organisation address
    C/ Villarroel 170, Barcelona, Spain,
    Public contact
    Joan Albert Arnaiz, CTU CLINIC, 34 932279838, jaarnaiz@clinic.cat
    Scientific contact
    Joan Albert Arnaiz, CTU CLINIC, 34 932279838, jaarnaiz@clinic.cat
    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
    11 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Nov 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Compare the clinical efficacy between two products in individuals who will undergo a colonoscopy in a CCR screening program.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki, ICH-GCP E6(R2) guidelines, EU Regulation 536/2014, and Spanish Royal Decree 1090/2015. The protocol was approved by the Ethics Committee for Research with Medicinal Products (CEIm) and authorized by the Spanish Agency of Medicines and Medical Devices (AEMPS). All participants provided written informed consent before enrolment. Subject confidentiality and data protection were ensured throughout the study. Safety monitoring included the collection and assessment of adverse events during trial participation.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Mar 2020
    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
    Spain: 1002
    Worldwide total number of subjects
    1002
    EEA total number of subjects
    1002
    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)
    739
    From 65 to 84 years
    263
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 1236 subjects were assessed for eligibility, of whom 1002 met inclusion criteria, provided informed consent, and were enrolled and randomized. No pre-assignment period was applied, and all exclusions occurred after randomization.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The endoscopist (outcome assessor) was blinded to treatment allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 1 L PEGA group
    Arm description
    		 1 L Polyethylene glycol plus ascorbate
    Arm type
    		 Experimental

    Investigational medicinal product name
    Polyethylene glycol 3350 plus ascorbate
    Investigational medicinal product code
    Other name
    Polyethylene glycol plus ascorbate, PEG 3350 + ascorbate, 1L-PEGA, Pleinvue
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Split-dose bowel preparation regimen: First dose: administered the evening before colonoscopy (20:00), consisting of polyethylene glycol 3350 with electrolytes dissolved in 500 mL water, ingested at approximately 250 mL every 15 minutes, followed by at least 500 mL of clear liquids. Second dose: administered approximately 4 hours before colonoscopy, consisting of polyethylene glycol 3350 plus ascorbate (two sachets) dissolved in 500 mL water, followed by at least 500 mL of clear liquids. Conducted under a low-residue diet for 2 days prior and liquid diet from the afternoon before the procedure.

    Arm title
    		 SPMc group
    Arm description
    		 Sodium picosulfate with magnesium citrate
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sodium picosulfate with magnesium citrate
    Investigational medicinal product code
    Other name
    Sodium picosulfate + magnesium citrate, SPMC, CitraFleet
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Split-dose bowel preparation regimen: First dose: administered the evening before colonoscopy (20:00), consisting of sodium picosulfate with magnesium citrate dissolved in approximately 250 mL of cold water. After intake, participants must drink at least 1.5 L of clear liquids (e.g. isotonic drinks, strained broth, or water, but not exclusively water). Second dose: administered approximately 4 hours before colonoscopy, identical to the first dose. Conducted under a low-residue diet for 2 days prior and liquid diet from the afternoon before the procedure.

    Number of subjects in period 1
    		1 L PEGA group SPMc group
    Started
    501
    501
    Completed
    450
    478
    Not completed
    51
    23
         Consent withdrawn by subject
    1
    -
         Physician decision
    1
    3
         Adverse event, non-fatal
    -
    3
         Lost to follow-up
    4
    11
         Protocol deviation
    45
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    1 L PEGA group
    Reporting group description
    		 1 L Polyethylene glycol plus ascorbate

    Reporting group title
    SPMc group
    Reporting group description
    		 Sodium picosulfate with magnesium citrate

    Reporting group values
    		 1 L PEGA group SPMc group Total
    Number of subjects
    		 501 501 1002
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 60 (55 to 65) 60 (55 to 65) -
    Gender categorical
    Units: Subjects
        Female
    		 239 232 471
        Male
    		 262 269 531

    End points

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    End points reporting groups
    Reporting group title
    1 L PEGA group
    Reporting group description
    		 1 L Polyethylene glycol plus ascorbate

    Reporting group title
    SPMc group
    Reporting group description
    		 Sodium picosulfate with magnesium citrate

    Primary: Percentage of ADR

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    End point title
    		 Percentage of ADR
    End point description
    ADR (adenoma detection rate): % of patients with ≥1 adenoma
    End point type
    Primary
    End point timeframe
    At the time of colonoscopy (single procedure)
    End point values
    		 1 L PEGA group SPMc group
    Number of subjects analysed
    501
    501
    Units: Number ob subjects
        ≥1 adenoma detected
    269
    283
        No adenoma detected
    232
    218
    Statistical analysis title
    		 Primary analysis of adenoma detection rate (ADR)
    Statistical analysis description
    The primary endpoint (adenoma detection rate, ADR) was analyzed as a proportion and compared between treatment groups. The difference in ADR and its two-sided 95% confidence interval were calculated. Non-inferiority was concluded if the lower limit of the confidence interval was above −10%.
    Comparison groups
    1 L PEGA group v SPMc group
    Number of subjects included in analysis
    1002
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Notes
    [1] - Non-inferiority analysis based on difference in proportions with a predefined margin of −10%.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of bowel preparation until 15 days after colonoscopy.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Not specified
    Dictionary version
    1.0
    Reporting groups
    Reporting group title
    1 L PEGA group
    Reporting group description
    		 1 L Polyethylene glycol plus ascorbate

    Reporting group title
    SPMc group
    Reporting group description
    		 Sodium picosulfate with magnesium citrate

    Serious adverse events
    		 1 L PEGA group SPMc group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 501 (0.20%)
    0 / 501 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Syncope
    Additional description: Dizziness and syncope with fall
         subjects affected / exposed
    1 / 501 (0.20%)
    0 / 501 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 1 L PEGA group SPMc group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    486 / 501 (97.01%)
    476 / 501 (95.01%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    486 / 501 (97.01%)
    476 / 501 (95.01%)
         occurrences all number
    486
    476

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jun 2020
    Protocol amendment version 3.0, date 15-Jun-2020

    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.
    Adverse events were collected via questionnaire without standardized coding, which may introduce reporting bias. The study was not powered for safety analysis.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/39069266
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    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.

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