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    Summary
    EudraCT Number:2006-002494-48
    Sponsor's Protocol Code Number:version 1.0, 02 May 2006
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-09-18
    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 number2006-002494-48
    A.3Full title of the trial
    Sildenafil in Crohn’s disease: an open label pilot study of Sildenafil in 15 patients with active colonic Crohn’s disease
    A.3.2Name or abbreviated title of the trial where available
    Sildenafil in active colonic Crohn’s disease
    A.4.1Sponsor's protocol code numberversion 1.0, 02 May 2006
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorUniversity College London / University College London Hospitals NHS Foundation Trust
    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 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 Viagra
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited, Sandwich, Kent. CT13 9NJ, United Kingdom
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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 No
    D.3.11.3.2Gene therapy medical product No
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeSelective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5)
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active colonic Crohn's disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10011402
    E.1.2Term Crohn's disease (colon)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether the Sildenafil-induced improvement in forearm blood flow demonstrated in patients with moderate to severe colonic Crohn’s disease translates into clinical benefits in patients with active disease.
    E.2.2Secondary objectives of the trial
    To determine whether orally administered Sildenafil citrate induces remission (absolute CDAI </=150) and reduces the endoscopic index of inflammation (Rutgeerts’ score) and histopathological grading of severity in patients with moderate to severe colonic Crohn's disease.

    To determine the effects of orally administered sildenafil citrate on colonic mucosal blood blow level, plasma neutrophil and white cell count, platelet count, erythrocyte sedimentation rate, serum C-reactive protein level and faecal calprotectin levels after a six week treatment period compared with baseline.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Able to give informed consent
    2) Definite diagnosis of colonic Crohn's disease based on radiological, endoscopic and/or histological criteria
    3) Moderate-to-severe disease activity, defined as a Crohn's Disease Activity Index (CDAI) score of 220475
    4) Patients on no medication, or having received stable doses of antibiotics, aminosalicylates or nutritional supplements for at least 4 weeks
    5) Patients on immunosuppressants (except steroids) must have received a stable dose for at least three months
    6) 18 years of age or older
    7) Able to comply with trial requirements (drug taking and visits)
    8) Negative serum pregnancy test in females of child-bearing potential, who must agree to use an adequate method of contraception for the duration of trial
    9) Stool sample negative for pathogenic bacteria, ova and/or parasites, and C. difficile toxin
    E.4Principal exclusion criteria
    1) Use of steroids within four weeks or infliximab within eight weeks of start of trial medication; use of any trial medication within the preceding 3 months
    2) Existing colostomy or ileostomy; current symptoms of bowel obstruction; any other severe concurrent morbidity including bleeding disorders or active upper gastrointestinal peptic ulceration; likely need for hospitalisation during the period of the study
    3) Recent stroke or myocardial infarction (within the preceding 6 months), unstable angina pectoris, moderate or severe cardiac failure, uncontrolled arrhythmias, uncontrolled hypertension, QT3 prolongation on ECG, any patient with hypotension or in whom vasodilation is clinically inadvisable
    4) Significant hepatic or renal dysfunction (ALT > twice ULN; creatinine > 149 micromol/L)
    5) Current use of any phosphodiesterase-5 inhibitor
    6) Current use of CYP 3A4 inhibitors (e.g. erythromycin, saquanavir, ketoconazole, itraconazole)
    7) Current use of organic nitrates or organic nitrites in any form (e.g. glyceryl trinitrate, isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil)
    8) Alpha-blocker therapy, unless stable dose for at least 1 month
    9) Prior episode non-arteritic anterior ischaemic optic neuropathy
    10) Previous adverse reaction to any phosphodiesterase-5 inhibitor
    11) Women who are currently or attempting to become pregnant, or those who are breast-feeding
    12) Male patients with anatomical deformation of the penis or predisposition to prolonged erection
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the proportion of patients experiencing a 100 point fall in the Crohn's disease activity index (CDAI score) at Week 6 (end of treatment) compared to baseline.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 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
    The trial will end at the time of the final patient's last visit (week 8; 2 weeks post end of treatment) unless unexpected adverse events occur or new data become available during the course of the trial, which would mandate early cessation.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned 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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 15
    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)
    Normal treatment and supervision will continue after the patients have completed their participation in the study. Patients will also continue to have telephone access to the trials coordinator should any queries arise.
    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 Decision2006-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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