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    Summary
    EudraCT Number:2023-000062-34
    Sponsor's Protocol Code Number:Reb-Oxy-OSA
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2023-01-23
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2023-000062-34
    A.3Full title of the trial
    Combination of Reboxetine 4mg and Oxybutynin 5mg for treating moderate obstructive sleep apnea: a one-month randomized placebo-controlled double-blind study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Combination of Reboxetine 4mg and Oxybutynin 5mg for treating moderate obstructive sleep apnea
    A.4.1Sponsor's protocol code numberReb-Oxy-OSA
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU Brugmann
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFonds Iris
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Brugmann
    B.5.2Functional name of contact pointSleep Laboratory (U78)
    B.5.3 Address:
    B.5.3.1Street Address4 Place A. Van Gehuchten
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1020
    B.5.3.4CountryBelgium
    B.5.4Telephone number3224772554
    B.5.6E-mailjohan.newell@chu-brugmann.be
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name EDRONAX
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer NV/SA
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNReboxetine
    D.3.9.3Other descriptive nameReboxetine
    D.3.9.4EV Substance CodeSUB15112MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Oxybutynine EG
    D.2.1.1.2Name of the Marketing Authorisation holderEurogenerics SA
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOxybutynin hydrochloride
    D.3.9.1CAS number 1508-65-2
    D.3.9.4EV Substance CodeSUB03581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Obstructive sleep apnea
    E.1.1.1Medical condition in easily understood language
    Obstructive sleep apnea
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 25.0
    E.1.2Level LLT
    E.1.2Classification code 10055577
    E.1.2Term Obstructive sleep apnea syndrome
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    50% reduction in apnea/hypopnea index (AHI) after 1 month of treatment compared to baseline.
    E.2.2Secondary objectives of the trial
    Significant improvements on different psychometric measurements (PSQI, ESS, FSS, FOSQ) as well as on other polysomnographic respiratory parameters (snoring, oxygen desaturation index – ODI, time spent below 90% oxygen saturation). Furthermore, we expect a good tolerance profile with a low number of drop-outs due to side effects. Finally, polysomnographic parameters related to sleep structure and quality (total sleep time – TST, sleep onset latency – SOL, wake time after sleep onset – WASO, sleep efficiency – SE, proportions of light sleep – N1/N2, deep sleep – N3, REM sleep, micro arousal index – MAI, intrusions of alpha waves in delta sleep) will be monitored.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients between 18 and 70 years suffering from moderate OSA (AHI 15 – 30/hour) diagnosed by a full in-hospital polysomnography (PSG).

    - Inclusion of patients should occur after a negative highly sensitive pregnancy test. Women of child bearing age (WOCBP) should use a highly effective method of contraception preferably with low user dependency*. Contraception should be maintained during treatment and until the end of relevant systemic exposure (day 30). Male healthy volunteers with a WOCBP partner should use a condom during treatment and until the end of relevant systemic exposure in WOCBP.

    *Birth control methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include:
    - combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation 1: o oral o intravaginal o transdermal
    - progestogen-only hormonal contraception associated with inhibition of ovulation:
    o oral
    o injectable
    o implantable
    - intrauterine device (IUD)
    - intrauterine hormone-releasing system ( IUS)
    - bilateral tubal occlusion
    - vasectomised partner (provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomised partner has received medical assessment of the surgical success).
    - sexual abstinence (only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments: 30 days. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject).
    E.4Principal exclusion criteria
    - Non-stabilized cardiovascular disorders
    - Medical history of urinary retention, intestinal occlusion, glaucoma, epilepsy, neurodegenerative disorders, unipolar and bipolar mood disorders.
    - Ongoing pharmacological treatments: antidepressants, antiepileptic drugs, antiparkinsonian drugs.
    - Ongoing treatment for Obstructive sleep apnea
    - Diagnosis of central sleep apnea (CSA) at baseline polysomnography
    - Pregnancy
    - Professional drivers
    E.5 End points
    E.5.1Primary end point(s)
    50% reduction in apnea/hypopnea index (AHI) after 1 month of treatment compared to baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 1 month of treatment
    E.5.2Secondary end point(s)
    Significant improvements on different psychometric measurements (PSQI, ESS, FSS, FOSQ) as well as on other polysomnographic respiratory parameters (snoring, oxygen desaturation index – ODI, time spent below 90% oxygen saturation). Furthermore, we expect a good tolerance profile with a low number of drop-outs due to side effects. Finally, polysomnographic parameters related to sleep structure and quality (total sleep time – TST, sleep onset latency – SOL, wake time after sleep onset – WASO, sleep efficiency – SE, proportions of light sleep – N1/N2, deep sleep – N3, REM sleep, micro arousal index – MAI, intrusions of alpha waves in delta sleep) will be monitored.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 1 month of treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2023-01-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-12-04
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