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    Summary
    EudraCT Number:2013-003187-31
    Sponsor's Protocol Code Number:GN09CA403
    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:2019-06-11
    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 number2013-003187-31
    A.3Full title of the trial
    Misoprostol for the Healing of Small Bowel Ulceration in Patients with Obscure Blood Loss while Taking Low-Dose Aspirin or Non-Steroidal Anti-inflammatory Drugs [MASTERS Trial]
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of gut ulcers in patients with low blood count or obscure internal bleeding while using aspirin or anti-inflammatory pain-killers
    A.3.2Name or abbreviated title of the trial where available
    Misoprostol for healing of small bowel ulcers in aspirin & NSAID users
    A.4.1Sponsor's protocol code numberGN09CA403
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02202967
    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 SponsorNHS Greater Glasgow & Clyde
    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 supportGastroenterology Endowment Fund/ NHS Ayrshire & Arran, Scotland
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNHS Ayrshire & Arran, University Hospital Crosshouse
    B.5.2Functional name of contact pointDr A S Taha
    B.5.3 Address:
    B.5.3.1Street AddressKilmarnock Road
    B.5.3.2Town/ cityKilmarnock
    B.5.3.3Post codeKA2 0BE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01563827280
    B.5.5Fax number01563827973
    B.5.6E-mailDr.Taha@aaaht.scot.nhs.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 Cytotec
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia Limited
    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 nameMisoprostol
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Capsule
    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 INNMisoprostol
    D.3.9.1CAS number 59122-46-2
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive name-
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboCapsule
    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
    Small bowel ulcers associated with iron deficiency anaemia or obscure blood loss in patients using aspirin or non-steroidal anti-inflammatory drugs
    E.1.1.1Medical condition in easily understood language
    Gut ulcers associated with low blood count or obscure internal bleeding in patients using aspirin or anti-inflammatory pain-killers
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066761
    E.1.2Term Acute anaemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10057220
    E.1.2Term Acute post haemorrhagic anaemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002034
    E.1.2Term Anaemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002034
    E.1.2Term Anaemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10002083
    E.1.2Term Anaemia- Hypochromic microcytic picture
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002062
    E.1.2Term Anaemia iron deficiency
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10014816
    E.1.2Term Endoscopy small intestine
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10014816
    E.1.2Term Endoscopy small intestine
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10014817
    E.1.2Term Endoscopy small intestine abnormal
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10014818
    E.1.2Term Endoscopy small intestine normal
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10041133
    E.1.2Term Small intestine ulcer
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10041133
    E.1.2Term Small intestine ulcer
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10041134
    E.1.2Term Small intestine ulcer haemorrhagic
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10055339
    E.1.2Term Small intestine ulcer hemorrhagic
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10045335
    E.1.2Term Ulcer small intestine
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In cases of iron deficiency anaemia or obscure gastrointestinal bleeding:
    To assess the efficacy of an off-patent prostaglandin analogue, misoprostol, in healing of small bowel mucosal damage while continuing to take low-dose aspirin and/ or NSAIDs
    E.2.2Secondary objectives of the trial
    To assess the change in haemoglobin level following the intake of misoprostol in patients with iron deficiency anaemia/ obscure blood loss and small bowel damage induced by low-dose aspirin or NSAIDs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    • Obscure occult gastrointestinal bleeding:
    • Iron deficiency anaemia (ferritin <100 ug/l, hemoglobin [Hb] 7–12 g/dl [female] or 7–13 g/dl [male])
    • Normal upper endoscopy and colonoscopy
    • Taking low-dose aspirin (75-325m/ day) or NSAIDs
    • Drop in haemoglobin, > 2gm/dl, over two measurements taken within 3 months of the screening visit, in the absence of potential or actively bleeding lesion detectable on upper endoscopy or colonoscopy.
    E.4Principal exclusion criteria
    Exclusion criteria
    Any of the following is regarded as criterion for exclusion from the study:

    1. Systemic disease that is unstable at the time of randomisation [unstable vital signs (pulse, blood pressure, respiratory rate, temperature, etc); ongoing non-gastrointestinal investigations; frequent (more than once/ week) modifications to treatment]
    2. Upper gastrointestinal lesions: oesophageal varices; erosive oesophagitis; oesophageal stricture; oesophageal or gastric neoplasms; pyloric stenosis; peptic ulcers; vascular malformations.
    3. Colonic disorders: neoplasms or adenomatous polyps; inflammatory bowel disease; vascular malformations; actively bleeding diverticular disease
    4. Pregnancy, lactation, or women of child-bearing potential not using two contraceptive methods, one of which must be highly effective, or planning pregnancy. “Women Not of Childbearing Potential” are defined as those women who are postmenopausal or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy). “Women of Childbearing Potential” are defined as any female who have experienced menarche and do not meet the criteria for “Women Not of Childbearing Potential”. “ Preferred Highly Effective Contraceptive Methods" are those with lower use dependency and include implants, injectables, and some intrauterine devices (IUDs). Combined oral contraceptives, sexual abstinence or vasectomised partner (provided that partner is sole sexual partner and that surgical success has been confirmed in the vasectomised partner) may also be used. Other contraception methods such as barrier contraception with our without spermicide may be used in combination with a highly effective method of contraception.
    5. Hypotension: systolic blood pressure <100-mm Hg.
    6. History of oesophageal, gastric or duodenal surgery, excluding simple closure of an ulcer or vagotomy.
    7. Current or historical evidence of any of the following diseases:
    a. Zollinger-Ellison syndrome.
    b. Primary oesophageal motility disorder(s) ie, achalasia, scleroderma, primary oesophageal spasm.
    c. Malabsorption.
    8. Significant cardiovascular, pulmonary, renal, pancreatic or liver disease as judged by the investigator to interfere with the evaluation of the study.
    9. Unstable diabetes mellitus (stable diabetes controlled by diet, oral agents or insulin is not an exclusion criterion).
    10. Cerebrovascular disease such as cerebral ischaemia, infarction, haemorrhage or embolus as judged by the investigator to interfere with the evaluation of the study.
    11. Suspected or confirmed current malignancy, except minor superficial skin disease.
    12. Use of any other investigational compound or participation in another clinical trial within the 90 days prior to start of study medication.
    13. Need for continuous concomitant therapy with:
    a. Warfarin
    b. High dose steroids (more than 7.5 mg of prednisolone or its equivalent daily).
    c. Cytotoxic drugs with the exception of methotrexate in patients with arthritis
    14. Alcohol and/or drug abuse or any condition associated with poor compliance including expected non-cooperation, as judged by the investigator.
    15. Previous participation in this study.
    16. Contraindications to study drugs, e.g., known or suspected allergy to misoprostol
    E.5 End points
    E.5.1Primary end point(s)
    Full healing of small bowel mucosal ulcers or erosions [in patients with iron deficiency anaemia or obscure blood loss, using misoprostol and while continuing on their aspirin or NSAIDs]
    E.5.1.1Timepoint(s) of evaluation of this end point
    Eight weeks post randomisation
    E.5.2Secondary end point(s)
    (i) Change in blood haemoglobin level
    (ii) Change in the numbers of mucosal erosions
    E.5.2.1Timepoint(s) of evaluation of this end point
    (i) Change in blood haemoglobin level: 4 and 8 weeks post randomisation

    (ii) Change in the numbers of mucosal erosions: 8 weeks post randomisation
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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) Yes
    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 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
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 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 state104
    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)
    Study drugs will be discontinued at the end of the 8-week period of the trial. It will not be possible to tell who took what as this is a double-blind trial
    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 NHS Ayrshire & Arran
    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 Decision2015-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-28
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