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    Summary
    EudraCT Number:2008-005961-77
    Sponsor's Protocol Code Number:3200K1-3357-WW
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-02-20
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-005961-77
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of
    Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation
    Estudio multicéntrico, aleatorizado, en doble ciego, controlado con placebo y de grupos paralelos, de MOA-728 subcutánea para el tratamiento del estreñimiento inducido por opiáceos
    A.4.1Sponsor's protocol code number3200K1-3357-WW
    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 SponsorWyeth Research Division of Wyeth Pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    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 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 nameMethylnaltrexone bromide for SC injection: 12 mg (0.6 mL, 20 mg/mL) in prefilled syringes
    D.3.2Product code MOA-728
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMethylnaltrexone Bromide
    D.3.9.1CAS number 73232-52-7
    D.3.9.2Current sponsor code0151, MNTX/MOA
    D.3.9.3Other descriptive nameNaltrexone Methobromide, N-methylnaltrexone Bromide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Opioid-induced constipation in subjects with non-malignant pain
    Tratamiento del estreñimiento inducido por opiáceos en sujetos con dolor de origen no maligno
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10010774
    E.1.2Term Constipation
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary: To evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with nonmalignant pain who have opioid-induced constipation.
    E.2.2Secondary objectives of the trial
    Secondary: To explore subject-reported outcomes for benefits of treatment with MOA-728.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects aged 18 years or older.
    2. Subjects weighing ? 40 kg.
    3. A history of pain with documentation of a nonmalignant condition underlying the pain of at least 2 month?s duration before the screening visit.
    4. Taking oral, transdermal, intravenous, or SC opioids for at least 1 month and receiving a daily dose ? 50 mg of oral morphine equivalents per day for at least 2 weeks before the screening visit with no anticipated changes during the study.
    5. A history of constipation due to opioid use for at least 1 month before the screening visit.
    Constipation is defined as < 3 rescue-free (no laxative use during the prior 24 hours)
    bowel movements (RFBMs) per week on average and 1 or more of the following:
    i) Hard or lumpy stools.
    ii) Straining during bowel movements.
    iii) A sensation of incomplete evacuation after bowel movements.
    6. All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after the last dose of test article administration. A subject is biologically capable of having children even if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.
    7. Willingness to discontinue all prestudy laxative therapy and use only the study-permitted rescue laxative during the screening, treatment, and follow-up periods.
    8. Willingness and ability to participate in all aspects of the study, including use of
    subcutaneous medication (administered by self or designee), completion of subject
    evaluations, attending scheduled clinic visits, access to a telephone, and compliance with all protocol requirements as evidenced by written informed consent.
    9. Ambulatory, capable of all self-care, and up and about more than 50% of waking hours.
    E.4Principal exclusion criteria
    1. Prior treatment with SC methylnaltrexone.
    2. Pregnant or breastfeeding women.
    3. A diagnosis of bowel obstruction, fecal incontinence, rectal prolapse, acute diverticulitis, or other significant GI disorders.
    4. Any history of any inflammatory bowel disease or toxic megacolon or a history of
    irritable bowel syndrome within 6 months before the screening visit.
    5. A recent history of rectal bleeding unexplained by hemorrhoids or fissures.
    6. Need for manual disimpaction or pelvic floor support techniques, including manual
    maneuvers, within 14 days before the screening visit.
    7. Clinical evidence of outlet obstruction or impaction. If suspected, a rectal examination must be performed to rule out obstruction or impaction.
    8. A history of malignancy, other than basal- or squamous-cell skin carcinoma, within
    5 years before the screening visit.
    9. A history of laxative use due to chronic constipation before the initiation of opioid
    therapy.
    10. A history of alcohol or drug abuse within 1 year before the screening visit.
    11. Any major illness/condition or unstable hepatic, renal, pulmonary, cardiovascular
    (including uncontrolled hypertension), ophthalmologic, neurologic, psychiatric, or any
    other medical condition that, in the investigator?s judgment, will substantially increase the risk associated with the subject?s participation in and completion of, the study, or could preclude the evaluation of the subject?s response.
    12. A history or presence of symptomatic orthostatic hypotension.
    13. Other clinically important abnormalities on screening physical examination findings, laboratory test results, or electrocardiogram (ECG) findings.
    14. A calculated creatinine clearance (Cockcroft-Gault glomerular filtration rate [GFR])
    < 30 mL/min.
    15. Planned surgery during the study.
    16. Known or suspected allergy to opioids, opioid derivatives, or opioid antagonists (eg, codeine, naltrexone, or naloxone) or other compounds related to these classes of medications.
    17. Current treatment with partial opioid agonists (eg, buprenorphine) or combination agonists/antagonists.
    18. Urine drug screen negative for the presence of opioids.
    19. Urine drug screen positive for a substance of abuse that is not explained by a prescribed medication reported by the subject.
    20. Patients who received opioid maintenance therapy (eg, methadone, buprenorphine) for the treatment of addiction.
    21. Involvement in litigation related to the subject?s underlying medical condition.
    E.5 End points
    E.5.1Primary end point(s)
    Two coprimary efficacy endpoints are:
    1. the proportion of subjects having a RFBM within 4 hours of the first dose administration, and
    2. the percentage of injections resulting in any RFBM within 4 hours during the double-blind period.
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Health outcomes
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    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) 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.8.3 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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.
    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 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 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 240
    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)
    At the conclusion of the follow-up period eligible subjects will have the opportunity to participate in a long-term open-label safety trial (3200K1-3358-WW).
    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 Decision2009-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-01
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