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    Summary
    EudraCT Number:2010-022897-14
    Sponsor's Protocol Code Number:PreMENAC-2011-01
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-18
    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 ConcernedNorway - NOMA
    A.2EudraCT number2010-022897-14
    A.3Full title of the trial
    PreMENAC: Multimodal Exercise/Nutrition/Anti-inflammatory treatment for Cachexia: A feasibility study (phase II)
    A.3.2Name or abbreviated title of the trial where available
    Pre - MENAC
    A.4.1Sponsor's protocol code numberPreMENAC-2011-01
    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 SponsorDep. of Cancer Research and Molecular medicine, Norwegian University of Science and Technology
    B.1.3.4CountryNorway
    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 Celebra
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameCelebra
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCELECOXIB
    D.3.9.1CAS number 169590-42-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 Yes
    D.3.11.13.1Other medicinal product typeNon-steroidal anti-inflammatory drug. Selective COX-2 inhibitor.
    D.IMP: 2
    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 Celebra
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameCelebra
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCELECOXIB
    D.3.9.1CAS number 169590-42-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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) 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 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 Yes
    D.3.11.13.1Other medicinal product typeNon-steroidal anti-inflammatory drug. Selective COX-2 inhibitor.
    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
    Diagnosis of non operable non-small cell lung cancer NSCLC (stage III-IV) or pancreatic cancer
    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 overall objectives are the feasibility of patient recruitment, compliance to the multimodal intervention as well as the assessment of possible contamination of the control group. This will be assessed by:
    • Patient recruitment
    • Compliance to the intervention and attrition
    • Compliance with the data collection procedures
    • Contamination of the control group
    E.2.2Secondary objectives of the trial
    This is a feasibility trial and all endpoints are related to compliance to the intervention and all over feasibility of the trial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of non operable non-small cell lung cancer NSCLC (stage III-IV) or pancreatic cancer
    2. Due to commence systematic chemotherapy or combination chemo-radiotherapy.
    3. Have a staging CT within 3 weeks of commencement of systemic chemotherapy/chemo-radiotherapy at study baseline
    4. 18–75 years of age
    5. A life expectancy of ≥4 months and is believed to be able to complete 2 months of intervention (based on clinical judgement)
    6. Karnofsky Performance Score ≥ 70
    7. Written informed consent
    8. Able to provide a blood sample
    E.4Principal exclusion criteria
    1. Renal impairment, creatinin clearance <30ml/min (estimated using cockroft-gault, creatinine measured within two months of date of consent)
    2. Receiving parenteral nutrition or enteral nutrition via feeding tube
    3. Weight loss >20% over the previous 6 months
    4. BMI >30 kg/m2
    5. Severe anorexia (less than 50% pre-illness food intake and unable to take oral supplements)
    6. Stated taking appetite stimulants such as megestrol acetate, progestational agents, steroids, growth hormone, dronabinol, marijuana or other anabolic agents
    7. Concomitant long term steroid treatment (inhaled, optical steroids or pulsed dexamethasone is permitted)
    8. Concomitant long term NSAID or Aspirin treatment.
    9. Regularly scheduled on kinase inhibitors (e.g. sorafinib)
    10. Women of child-bearing age who not using adequate contraception
    11. Positive history of heart disease, i.e., severe (New York Heart Association Functional class III or IV) heart failure, uncontrolled hypertension (diastolic blood pressure >95 mmHg at screening), history of previous myocardial infarction, unstable angina, coronary revascularization, uncontrolled arrhythmia, and cerebrovascular accident
    12. Previous gastrointestinal inflammatory disease and history of gastrointestinal ulceration
    13. History of bronchospasm, asthma, rhinitis, or urticaria with NSAID or aspirin therapy
    14. Ongoing/planned radiotherapy during the study period affecting the gastric/oesophagus area
    E.5 End points
    E.5.1Primary end point(s)
    1. Feasibility of Recruitment

    This is assessed by:
    • The number/percentage of potentially eligible patients
    • The number/percentage of patients accepting to participate to the study
    • The number/percentage of patients who start the study protocol
    • Where are the patients recruited from?
    • Who do we recruit into the study? What characterize the participants?
    • Are the eligibility criteria feasible?

    2. Compliance to the Intervention

    This is assessed by:

    • Nutrition:
    Data on dietary intake using the 24 h recall method
    Nutrition -10-point verbal analogue scale (AveS) for dietary intake
    Daily log for the compliance of oral nutritional supplement (ONS)
    Serum values of eicosapentaenoic acid (EPA) will be measured as a biomarker of compliance
    with the intake of the ONS

    • Anti-inflammatory medication:
    The remaining pills will be counted at week 3 and 6 during the intervention and registered by a study investigator (by phone or e-mail)

    • Physical exercise
    Daily completed exercise sessions/daily walks is registered in an activity calendar and returned to the study nurse at 3 and 6 weeks

    • Registration of number of adverse events

    • The number/percentage of patients who drop out at various stages of the study and reasons for drop out

    3. Compliance with the Data Collection Procedures

    This is assessed by:

    • Patient Reported Outcomes –
    o Completion rates (%) or number of missing items in questionnaires.
    o Reasons for withdrawal or missing data
    • Objective measures of physical- performance and activity
    o Completion rates (%) or missing data in physical testing – reasons for withdrawal or missing data
    o ActivPAL - missing data (removal of sensor, loss of data, technical difficulties, patient discomfort – reasons for withdrawal or missing data
    o Biomarkers
    o No. of blood/urine sample collected
    o Reports of technical difficulties

    4. Contamination of the Control Group

    This is assessed by:
    • Serum values of eicosapentaenoic acid (EPA) will be measured as a biomarker of contamination of the control group at baseline and at end of study
    • Data on dietary intake using the 24 h recall method and Nutrition -10-point verbal analogue scale (AveS) for dietary intake will also provide information about change in dietary intake

    • Registration on the use of NSAIDs in the control group (medications last 24 hours)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Control group (standard care)
    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 concerned3
    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 Yes
    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
    For the purposes of Clinical Trial Authorisation the trial is deemed to have ended 30 days
    after follow-up. For the purposes of the ethics, the study end date is deemed to be the date of the last data capture.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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 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.1.3Elderly (>=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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 40
    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 control arm is offered the same treatment as the intervention arm after 6 weeks.
    Following study endpoint at 6 weeks, each centre will decide individually if the patients are able to continue the anticachexic treatment or not.
    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 Decision2011-05-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-01
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