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    Summary
    EudraCT Number:2007-001335-54
    Sponsor's Protocol Code Number:AFX-01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-06-18
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-001335-54
    A.3Full title of the trial
    SAFETY AND EFFICACY OF CIMICOXIB, A SELECTIVE COX-2 INHIBITOR, IN COMBINATION WITH SERTRALINE COMPARED TO SERTRALINE COMBINED WITH PLACEBO IN TREATMENT OF MAJOR DEPRESSION
    A.3.2Name or abbreviated title of the trial where available
    SECIM
    A.4.1Sponsor's protocol code numberAFX-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 SponsorAffectis Pharmaceuticals AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 Sertralin
    D.2.1.1.2Name of the Marketing Authorisation holderHexal AG
    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.3.4Pharmaceutical 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSertralin
    D.3.9.1CAS number 79559-97-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    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 No
    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 nameCimicoxib
    D.3.2Product code Cimicoxib
    D.3.4Pharmaceutical form Tablet
    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 INNCimicoxib
    D.3.9.1CAS number 265114-23-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 placeboTablet
    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
    major depression
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10057840
    E.1.2Term Major depression
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the mean change on the total score of the Hamilton Depression Rating Scale (HamD-17) items from baseline to endpoint (Week 6).
    The main objective of this study is to evaluate whether patients treated with sertraline and cimicoxib have a higher mean HamD-17 change than patients treated with sertraline and placebo.
    E.2.2Secondary objectives of the trial
    • Changes from baseline to interim weekly visits (week 1 to 5) in HamD-17 score
    • Clinical Global Impression (CGI) score
    • Montgomery Asberg Depression Rating Scale (MADRS) score
    • Response rate, remission rate and drop out rate. Response will be defined as a decrease from baseline in total HamD-17 score of at least 50%. Remission will be defined as a total HamD-17 score of less than 7
    • Onset of action, i.e. percentage of patients with a reduction from baseline in HamD-17 score of at least 20% within 2 weeks
    • Use of concomitant benzodiazepines
    • Sertralin dose increase after 3 weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Major depression diagnosed by psychiatrist
    2. DSM IV TR: 296.2x single depressive episode or 296.3x recurrent depressive episode
    3. HamD-17 score ≥ 22
    4. Informed consent
    5. Age between 18 and 60 years
    E.4Principal exclusion criteria
    1. Psychotic depression or bipolar disorder, obsessive compulsive disorder, anxiety disorder, personality disorder, drug or alcohol abuse, schizoaffective disorders, schizophrenia
    2. All DSM IV TR Axis-I disorders except depression
    3. All DSM IV TR Axis-II disorders without exception
    4. Unsuccessful treatment with more than 2 antidepressant medications (at therapeutically adequate doses and duration)
    5. Concomitant use of psychotropic drugs, including mood stabilizers
    6. Immediate risk for suicidal behaviour (3 on HamD-17 rating scale or 5 on MAD Rating Scale)
    7. Women who are pregnant, breast feeding or planning to become pregnant during the course of study
    8. Women who are not post-menopausal (no natural menopause established in retrospect after 12 consecutive months of amenorrhoea without hormone replacement therapy during the last 5 months), surgically sterilized or using a highly effective method of contraception (an implanted or injected hormonal contraceptive, some intrauterine contraceptive devices (IUDs) containing hormones, sexual abstinence, or have a vasectomised partner). Females using combined oral contraceptives should use a different or additional highly effective method of contraception as listed above.
    9. Any history of cardiovascular disease (e.g. angina, heart attack, stroke, congestive heart failure), uncontrolled high blood pressure, documented peripheral arterial insufficiency and symptomatic, clinically significant claudication, or a history of peripheral arterial embolism
    10. Patients at risk of QT/QTc interval prolongation (QTC> 450 ms, family history of long QT syndrome or use of medication prolonging QT/QTc interval)
    11. History of coronary heart disease (CHD) or any other heart disease
    12. Serum NTproBNP ≥ 125 pg/ml indicating (sub-)clinical heart failure
    13. History of upper or lower gastrointestinal (GI) ulceration, perforation and/or obstruction
    14. History of upper or lower GI bleeding within the previous year
    15. History of inflammatory bowel disease
    16. Undergoing cancer chemotherapy
    17. Known HIV infection or clinically manifest Acquired Immune Deficiency Syndrome (AIDS), liver function tests (AST, ALT) > 2x ULN, diabetes, asthma, COPD, Parkinson’s or Alzheimer’s disease, or any other serious condition likely to interfere with the conduct of the trial
    18. Clinically relevant hepatic or renal impairment, or other clinically significant physical findings or clinically significant laboratory results at screening or baseline, as determined by the investigator
    19. History of allergy to sertraline, cimicoxib or closely related compounds or excipients
    20. History of hypersensitivity or intolerance to pain medications
    21. Currently taking a monoamine oxidase inhibitor (MAOI) or within 14 days of discontinuing treatment with an MAOI
    22. Currently taking pimozide
    23. Currently taking fluoxetin
    24. Use of pain medication, such as a COX-2 inhibitor, NSAID (non-steroidal anti-inflammatory drug, including aspirin) or acetaminophen (paracetamol) within 72 hours prior to study entry (24 hours for short-acting drugs such as aspirin or acetaminophen)
    25. Currently taking sucralfate or misoprostol
    26. Participation in a study of an investigational drug or device concomitantly or within 30 days prior to this study
    27. Patients thought to be unreliable or incapable of complying with the requirements of the protocol
    28. Positive drug test (except for benzodiazipine)
    29. Patient is relative of, or staff directly reporting to the investigator
    30. Patient is employee of the sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy will be assessed according to guideline CPMP/EWP/518/97 Rev 1 (Note for guidance on clinical investigation of medicinal products in treatment of depression) using the HamD-17 rating scale for depression. The investigators will be trained in the use of these rating scales.

    Determination of the response rate (i.e. proportion of patients with > 50% improvement of HamD 17), are also consistent with the requirements of the CPMP guideline.

    The safety assessments include standard parameters (adverse events, clinical laboratory tests, 12-lead ECGs and vital signs) as well as additional cardiovascular safety assessment (at screening) in view of the known class effects of COX-2 inhibitors and the finding in non-clinical studies with cimicoxib. Therefore patients with coronary heart disease (CHD) or any other heart disease will be excluded from the study.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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.8.3 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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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 end of the study is defined as the last telephone follow up of the last patient 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 months3
    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 months3
    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) No
    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 2007-06-18. Yes
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    There is no study-specific provision of further treatment and additional medical care of the patients once their participation in the trial has ended. Afterwards the patient will be treated with the antidepressant prescribed by his/her general practitioner.

    Even if the study medication was identified as beneficial in the study, it can not be provided to the patients since further studies investigating the safety and efficacy of this medication are necessary. (Protocol section 8.3)
    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 Decision2007-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-02-16
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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