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    Summary
    EudraCT Number:2015-005247-14
    Sponsor's Protocol Code Number:CHUB-Equidol
    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:2016-06-30
    Trial results View 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 number2015-005247-14
    A.3Full title of the trial
    Effect of levobupivacaine infiltration versus placebo on perineal postpartum pain in episiotomy of primiparous, after instrumental delivery: randomized double blind clinical trial.
    Effet sur la douleur périnéale du post-partum de l’infiltration de lévobupivacaïne versus placebo dans l’épisiotomie des primipares après extraction instrumentale: essai randomisé en double aveugle.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of levobupivacaine infiltration versus placebo on perineal postpartum pain in episiotomy of primiparous, after instrumental delivery.
    A.4.1Sponsor's protocol code numberCHUB-Equidol
    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 SponsorCentre Hospitalier Universitaire 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 supportCHU Brugmann
    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 pointGynecology-Obstetrics Department
    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 number322477.29.30
    B.5.6E-mailandre.nazac@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 Levobupivacaïne Fresenius Kabi
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi nv
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVOBUPIVACAINE HYDROCHLORIDE
    D.3.9.1CAS number 27262-48-2
    D.3.9.3Other descriptive nameLEVOBUPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02904MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboInfiltration
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Episiotomy (inclusion of primiparous patients giving birth by instrumental delivery -Suzor forceps, vacuum extraction, Thierry spatulas with episiotomy).
    E.1.1.1Medical condition in easily understood language
    Episiotomy
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of the infiltration of levobupivacaine versus placebo on perineal pain after episiotomy in patients under epidural anesthesia.
    E.2.2Secondary objectives of the trial
    - Estimate the amount of analgesics taken in the first 48 hours, then in the first 15 days postpartum
    - Evaluate the slowing down of the daily activities of patients within the first 15 days postpartum
    - Assess the pain at J15 postpartum on a simple numeric scale
    - Evaluate the healing of episiotomy at J15 postpartum
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Primiparous
    -Vaginal delivery with instrumentation (Suzor forceps, vacuum extraction, Thierry spatulas), with episiotomy
    -Fœtus In cephalic position
    -Single pregnancy
    -Patient at least 18 years old
    -Term superior or equal to 37 weeks of amenorrhea
    -Patient under epidural analgesia
    -Patient affiliated to a social security scheme
    -Patient having a good understanding of French
    E.4Principal exclusion criteria
    -Ineffective epidural analgesia, defined as the need of an additional local anesthesia for episiotomy repair
    - Perineal tear of 3rd and 4rd grade, according to the Anglo-saxon classification
    - Contra-indication to levobupivacaine, paracetamol, ketoprofen
    - Protocol participation refusal
    - Postpartum hemorrhage requiring arterial embolization, reoperation (evacuation of a vaginal thrombus, vessel ligation, hysterectomy by laparotomy) or balloon Bakri® placement.
    E.5 End points
    E.5.1Primary end point(s)
    Pain evaluation on a simple numeric scale (ENS)

    E.5.1.1Timepoint(s) of evaluation of this end point
    24 h post partum
    E.5.2Secondary end point(s)
    - Need for analgesics and quantity of analgesics taken in addition to paracetamol in the first 48 hours postpartum (ketoprofen, nefopam).
    - Need for analgesics and amount of analgesics taken on Day 15 postpartum
    - Impact of pain secondary to episiotomy on the daily life activities on Day1, Day2 and Day15 after delivery (sitting, walking, urinating, sleep, child care).
    - ENS on Day 15 post-partum
    - Control of episiotomy healing at Day15 post partum
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Need for analgesics :in the first 48 hours postpartum
    - Need for analgesics : on Day 15 postpartum
    - Impact of pain secondary to episiotomy on the daily life activities: Day1, Day2 and Day15 after delivery
    - ENS on Day 15 post-partum
    - Control of episiotomy healing at Day15 post partum
    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 No
    E.6.4Safety No
    E.6.5Efficacy Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    Last patient last visit
    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
    E.8.9.2In all countries concerned by the trial years2
    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: 330
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state165
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 330
    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)
    Patients will be treated according to the standard of care.
    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 Decision2016-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
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