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    Summary
    EudraCT Number:2015-003628-29
    Sponsor's Protocol Code Number:REGC-15-035.R1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-003628-29
    A.3Full title of the trial
    The introduction and use of Entonox as an alternative method of pain relief for intrauterine contraception device insertions.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The introduction and use of Entonox® as an alternative method of pain relief for intrauterine contraceptive device insertion.
    A.3.2Name or abbreviated title of the trial where available
    Entonox as an alternative method of pain relief for IUCD insertion.
    A.4.1Sponsor's protocol code numberREGC-15-035.R1
    A.5.4Other Identifiers
    Name:EudraCT numberNumber:2015-003628-29
    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 SponsorUniversity of Brighton
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Brighton
    B.5.2Functional name of contact pointTheofanis Fotis
    B.5.3 Address:
    B.5.3.1Street AddressSchool of Health Sciences
    B.5.3.2Town/ cityWestlain House, Village Way
    B.5.3.3Post codeBN1 9PH
    B.5.4Telephone number01273 644512
    B.5.6E-mailT.Fotis@brighton.ac.uk
    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 Entonox
    D.2.1.1.2Name of the Marketing Authorisation holderBOC Healthcare
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.1Product nameNitrous Oxide (50%) and Oxygen (50%) mixture
    D.3.4Pharmaceutical form Inhalation vapour
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNitrous Oxide 50% and Oxygen 50%
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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 RoleComparator
    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 Lidocaine 1%
    D.2.1.1.2Name of the Marketing Authorisation holderBBraun
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.1Product nameLidocaine 1% solution for injection
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracervical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLidocaine Hydrochloride BP
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number50mgms to 5mls
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    This study is to investigate the efficacy of 2 methods of pain relief during the procedure of an intrauterine contraceptive device insertion (coil). There is no medical condition or disease under investigation
    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
    The principal research objective is to see if Entonox® helps to reduce the level of pain experienced by women during intrauterine contraception device insertions in a community contraception and sexual health clinic compared to local anaesthetic intracervical injection.
    E.2.2Secondary objectives of the trial
    The secondary objective is whether the use of a self administered and regulated analgesic (Entonox®) which empowers the patient to have control over their pain relief and management improves the overall satisfaction with pain relief received for this procedure.

    Additional areas for exploration are whether level of pain and analgesic efficacy is related to participants age, parity (number of pregnancies and mode of delivery) and/or previous intrauterine contraception device insertion experience.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants will be women aged 18-54 years old, 54 years being the maximum age for IUC provision for women in East Sussex Healthcare NHS Trust Community Sexual Health Service as per professional guidelines (Faculty of Sexual and Reproductive Healthcare, 2010).
    Women requesting IUC as their preferred method of contraception.
    Women who fulfil the eligibility criteria for an IUCD insertion.
    Women requesting analgesia for IUCD insertion.
    E.4Principal exclusion criteria
    Any women not eligible for IUCD insertion.
    women less than 18 years of age or more than 54 years of age.
    Women who decline a local anaesthetic intracervical injection or decline to use an inhalation analgesic.
    Women for whom lidocaine local anaesthetic is contra-indicated, to include;
    -Known hypersensitivity to Lidocaine, or any other aesthetics of the amide type or any components of the injection.
    -Previous maximum infiltration of local anaesthetic within 4 hours.
    -Complete heart block or congestive cardiac failure.
    -Hypovolaemia.
    -Inflamed or infected tissue at injection site.
    -Participant on Fosamprenavir or Saquinavir.
    Women for whom Entonox is contra-indicated, to include;
    -women who cannot use a mouthpiece or who are unable to co-operate e.g. Intoxication.
    -Participants who have any condition where air is trapped in the body and its expansion would be dangerous E.G.; Underwater diving in last 24hrs.
    -Middle ear disease where there is blockage of the Eustation tube.
    -Use of central acting depressant and their derivatives E.G. strong opiate based medication/benzodiazepines.
    -Any use of Entonox within previous 4 days.
    E.5 End points
    E.5.1Primary end point(s)
    To measure pain scores at tenaculum placement and IUCD insertion using a 100mm VAS scores
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation will occur at two points within the procedure for IUCD insertion that are know to be potentially painful, tenaculum (surgical clamp) placement to the cervix to provide traction and stabilise the cervix and insertion of a uterine measuring device and contraceptive device through the cervix and into the uterus. End point will occur following insertion of the intrauterine contraceptive device.
    E.5.2Secondary end point(s)
    To measure satisfaction with the procedure using 2 Likert scale questions.
    E.5.2.1Timepoint(s) of evaluation of this end point
    These questions will be asked following completion of the procedure. End point will be completion of the IUCD insertion appointment.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Information not present in EudraCT
    E.8.2.3.1Comparator description
    local anesthetic intracevical injection of 1% lidocaine
    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 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 years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 58
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    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 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 state58
    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)
    The costs for the provision of this treatment are being met by the East Sussex Healthcare NHS trust Sexual Health Service as this medication is registered for the use of procedural pain and can be used for other potentially painful procedures within this community contraception and sexual health clinic. Following the research study, it is anticipated that if effective, Entonox® will be available to be offered to women requesting IUCD device insertion.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation East Sussex Healthcare NHS Trust, Research Governance and Facilitator, District General Hospital
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-04
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