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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41501   clinical trials with a EudraCT protocol, of which   6826   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Summary
    EudraCT Number:2009-014375-50
    Sponsor's Protocol Code Number:YDH/09/01
    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:2010-10-20
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-014375-50
    A.3Full title of the trial
    Comparison of the Efficacy of Thoracic Epidural Analgesia and a Local Anaesthetic Wound Infusion Catheter after Laparoscopic Colectomy within the Enhanced Recovery Programme : a pilot RCT
    A.3.2Name or abbreviated title of the trial where available
    Epidural vs Wound Infusion Catheter (E-WIC) v1.0
    A.4.1Sponsor's protocol code numberYDH/09/01
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbernot available
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorYeovil District Hospital
    B.1.3.4Country
    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 organisation
    B.5.2Functional name of contact point
    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 Chirocaine 2.5mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Limited, Queenborough, Kent, ME11 5EL
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInfiltration use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlevobupicavaine
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.3.11.13.1Other medicinal product typeLocal anaesthetic, amide
    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 placeboIrrigation solution
    D.8.4Route of administration of the placeboInfiltration use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients undergoing elective laparoscopic colectomy for either benign or malignant tumour in the right or left colon with intention to cure.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12
    E.1.2Level LLT
    E.1.2Classification code 10009944
    E.1.2Term colon cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12
    E.1.2Level LLT
    E.1.2Classification code 10009946
    E.1.2Term Colon Cancer Duke's A
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12
    E.1.2Level LLT
    E.1.2Classification code 10009947
    E.1.2Term Colon Cancer Duke's B1
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12
    E.1.2Level LLT
    E.1.2Classification code 10009948
    E.1.2Term Colon Cancer Duke's B2
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12
    E.1.2Level LLT
    E.1.2Classification code 10009949
    E.1.2Term Colon Cancer Duke's C
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12
    E.1.2Level LLT
    E.1.2Classification code 10009952
    E.1.2Term Colon Cancer Recurrent
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12
    E.1.2Level LLT
    E.1.2Classification code 10009953
    E.1.2Term Colon Cancer Stage I
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12
    E.1.2Level LLT
    E.1.2Classification code 10009954
    E.1.2Term Colon Cancer Stage II
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12
    E.1.2Level LLT
    E.1.2Classification code 10009955
    E.1.2Term Colon Cancer Stage III
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This pilot aims to test the feasibility of a large Randomised Control Trial (RCT). The full RCT is to compare the effectiveness of wound infusion catheter (WIC) and standard epidural analgesia following laparoscopic colectomy (key hole surgery to remove part of the large bowel) within an Enhanced Recovery Programme. The pilot will provide information on rates of recruitment, data collection and descriptive information on the outcome measures to aid power calculations (which tell us how many patients will be needed in the full RCT). It will also test the ability to successfully blind patients and research personnel to group allocation. This means that they will not know which treatment they are having, and hleps prevent the results from being biased.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients undergoing elective laparoscopic colectomy for either benign or malignant tumour in the right, left or transverse colon with intention to cure.
    2. Aged 18 or over with Americal Society of Anaesthesiology (ASA) score I, II or III.
    3. Able and willing to provide written consent.
    E.4Principal exclusion criteria
    1. Transverse colon or rectal tumour.
    2. Locally advanced or widespread disease - stage T4 on CT scan - palpable mass or distant metastasis.
    3. Emergency admission or obstruction/perforation of bowel cancer.
    4. Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis).
    5. Known allergy to local anaesthetic.
    6. Multiple Sclerosis or chronic pain requiring regular strong opioid analgesia.
    7. Recent history of alcohol or drug abuse.
    8. Contraindication to epidural analgesia.
    9. Poor cognitive ability.
    10. Pregnant patients.
    E.5 End points
    E.5.1Primary end point(s)
    Patient reported pain assessment as measured by the Memorial Pain Assessment Card at intervals throughout the patient stay.
    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 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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To test feasibility of a large scale randomised controlled trial.
    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 Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    placebo - saline via wound infusion catheter. Comparator standard epidural analgesia
    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 Information not present in EudraCT
    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 visit of the last subject undergoing the trial.
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 2010-10-20. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    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 state50
    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 follow up care will be the same as for all colorectal surgery patients at the centre from which they are enrolled.
    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 Decision2009-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-21
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