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    Summary
    EudraCT Number:2012-004311-31
    Sponsor's Protocol Code Number:0177/DEV
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-22
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-004311-31
    A.3Full title of the trial
    Randomised, double-blind, placebo-controlled, parallel-group design, multi-centre, dose-escalation phase III trial to investigate the efficacy, safety, and tolerability of Naloxone HCl PR tablets administered in a dose range of 6 mg to 48 mg once daily in patients with opioid induced constipation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to investigate the efficacy, safety and tolerability of Naloxone in patients with opioid induced constipation.
    A.4.1Sponsor's protocol code number0177/DEV
    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 SponsorDevelco Pharma Schweiz AG
    B.1.3.4CountrySwitzerland
    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 supportDevelco Pharma Schweiz AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDevelco Pharma Schweiz AG
    B.5.2Functional name of contact pointSponsor Clinical Team
    B.5.3 Address:
    B.5.3.1Street AddressHohenrainstr. 12 D
    B.5.3.2Town/ cityPratteln
    B.5.3.3Post code4133
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41614255020
    B.5.5Fax number+41614255029
    B.5.6E-mailinfo@develco.ch
    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 nameNaloxone Hydrochloride Prolonged Release Tablets
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNNaloxone Hydrochloride Prolonged Release
    D.3.9.1CAS number 357-08-4
    D.3.9.3Other descriptive nameNALOXONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03382MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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.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 nameNaloxone Hydrochloride Prolonged Release Tablets
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNNaloxone Hydrochloride Prolonged Release
    D.3.9.1CAS number 357-08-4
    D.3.9.3Other descriptive nameNALOXONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03382MIG
    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) 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.IMP: 3
    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 nameNaloxone Hydrochloride Prolonged Release Tablets
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNNaloxone Hydrochloride Prolonged Release
    D.3.9.1CAS number 357-08-4
    D.3.9.3Other descriptive nameNALOXONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03382MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number24
    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.IMP: 4
    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 nameNaloxone Hydrochloride Prolonged Release Tablets
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNNaloxone Hydrochloride Prolonged Release
    D.3.9.1CAS number 357-08-4
    D.3.9.3Other descriptive nameNALOXONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03382MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number48
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 5
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Opioid-induced bowel dysfunction (OBD) involves not only constipation, but also a constellation of symptoms including incomplete evacuation, bloating, abdominal distension, and increased gastric reflux.
    Constipation is an almost inevitable consequence of opioid use in malignant and non-malignant disease states, and one of the side effects of opioids to which few patients develop tolerance.
    E.1.1.1Medical condition in easily understood language
    Constipation, defined as "the evacuation of hard stools less frequently than is normal for the individual", is an almost inevitable side effect of opioid use.
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10071128
    E.1.2Term Opioid induced constipation
    E.1.2System Organ Class 100000004856
    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 the trial is to demonstrate that administration of Naloxone HCl PR (prolonged-release) tablets once daily is superior to Naloxone HCl PR Placebo in the improvement / reversal of opioid-induced constipation (OIC) as determined by the Bowel Function Index (BFI).
    E.2.2Secondary objectives of the trial
    Secondary objectives are to assess the efficacy of Naloxone HCl PR
    tablets administered once daily in the treatment of OIC in terms of
    decreased BFI and increased frequency in bowel movements, improvement of stool consistency and symptoms of defecation, global improvement of OIC and on changes of constipation-related quality of life as well as in terms of reduction of the number of days with laxative rescue medication.
    The safety of starting dose is to be reaffirmed and dose regimen is to be determined. In addition, safety and tolerabiliy, the effect of abrupt versus tapered cessation, the non-inferiority regarding induced pain relief, the lack of systemic effects in terms of opioid withdrawal symptoms, the rate of treatment failures and effects on non-responders to standard laxatives of Naloxone HCl PR tablets administered once daily are to be assessed.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects ≥18 years of age.
    2. Subjects with a documented history of constipation induced or worsened by their oral, transdermal or sublingual WHO step-II or step-III opioid medication.
    3. Requirement of laxatives to have bowel movements (BMs), or having less than 3 BMs per week when not taking laxatives, respectively.
    4. Subjects with documented history of chronic severe non-malignant pain that requires around-the-clock opioid therapy and likely to benefit from WHO step-III opioid therapy for the duration of the trial.
    5. Subjects with predominantly non-neuropathic pain, as determined by a DN4 Neuropathic Pain Diagnostic Questionnaire score < 4 .
    6. Subjects willing and able (e.g. mental and physical condition) to participate in all aspects of the trial, including use of medication, completion of subjective evaluations, attending scheduled visits, completing telephone interviews, and compliant with protocol requirements as evidenced by providing signed written informed consent.
    E.4Principal exclusion criteria
    1. Subjects with any situation in which opioids are contra-indicated, severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, paralytic ileus.
    2. Hypersensitivity or intolerance to any active substance, i.e. oxycodone, hydromorphone, morphine, naloxone, bisacodyl, or any of the excipients of the trial medication, e.g. subjects with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
    3. Intake of naloxone or naltrexone or injection of methylnaltrexone within the past 30 days prior to Visit 1.
    4. Subjects unwilling to discontinue pre-trial laxative medication (except fibre supplementation or bulking agents at a stable dose) and take trial specific laxative medication.
    5. Any gastrointestinal pathology or surgery or intractable vomiting likely to significantly influence drug absorption.
    6. Inability to swallow the trial drugs whole (e.g. due to dysphagia).
    7. Surgery within 1 month, radiotherapy or neural blockade 2 weeks prior to Visit 1 and/or anticipated and/or scheduled during the course of the trial.
    8. Evidence of impaired hepatic function (total bilirubin, aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyltransferase [GGT], or alkaline phosphatase [AP] >3 times the upper limit of normal).
    9. Evidence of impaired renal function (creatinine clearance [CRCL] <90 mL/min).
    10. Known or suspected significant hypotension, shock or severe cardiovascular disease.
    11. Known or suspected clinically relevant endocrine disorder, such as myxoedema, not adequately treated hypothyroidism or adrenocortical insufficiency (e.g. Addison's disease)
    12. Known or suspected clinically significant bowel disease (e.g. paralytic ileus, significant impairment of bowel motility severe enough to potentially result in ileus, obstructive or inflammatory bowel disease, anal fissures or ulcerative proctitis).
    13. Subjects with a confirmed diagnosis of ongoing irritable bowel syndrome.
    14. Known or suspected acute or chronic pancreatitis or clinically relevant biliary tract disease.
    15. Known or suspected significant prostatic hypertrophy or urethral stricture severe enough to potentially result in acute urinary retention.
    16. Known or suspected CNS depression (signs/symptoms: decreased vital signs, impaired thinking and perception, slurred speech, slowed reflexes, fatigue, decreased consciousness), coma, or convulsive disorder.
    17. Known or suspected cranio-cerebral trauma or elevation of intracranial pressure.
    18. Known or suspected acute alcoholism, delirium tremens, or toxic psychosis.
    19. Known or suspected severe psychiatric disorders.
    20. History of drug addiction or drug seeking behaviour, positive test of illicit drugs at screening.
    21. Concomitant treatment with other naloxone preparations (apart from IMP), naltrexone or methylnaltrexone preparations, other laxatives (except stable therapy with fibre supplementation or bulking agents), other medicines that can cause constipation or influence bowel motility, other opioid analgesics (including codeine-containing compounds), non-opioid analgesics taken on an as-needed basis, monoamine oxidase (MAO) inhibitors or any form of neural blockade or radiotherapy. Substantial changes in concomitant therapies with other compounds that can influence pain response such as nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) inhibitors, paracetamol, corticosteroids, anti-depressants, anxiolytics, neuroleptics or non-drug treatments such as physical measures or acupuncture.
    22. For women: Pregnancy or breast-feeding. Women of childbearing potential unable or unwilling to undergo pregnancy tests and practice adequate contraceptive measures. Reliable methods for women are hormonal contraceptives, surgical intervention (e.g. tubal ligation), intrauterine device (IUD), double-barrier methods and sexual abstinence. For men: Men unable or unwilling to practice adequate contraceptive measures. Reliable methods for men are surgical intervention (e.g. vasectomy), double-barrier methods, sexual abstinence and reliable contraception (as described above) of the female partner.
    23. Any other condition of the subject that in the opinion of the investigator may compromise evaluation of the trial treatment or may jeopardise subject's safety, compliance or adherence to protocol requirements.
    24. Previous enrolment in this trial or participation in any other drug investigational trial within the past 30 days (or five half-lives of IMP whichever is longer) prior to Visit 1.
    25. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
    26. Employees of the investigator or trial centre as well as family members of the employees or the investigator
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point is defined as the absolute change in BFI score at the end of Week 12 (Visit 11) compared to baseline (Visit 4).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary end point is evaluated at the end of the trial
    E.5.2Secondary end point(s)
    1. Relative change in BFI score at the end of Week 12 (Visit 11)
    compared to baseline (Visit 4)
    2. Absolute and relative changes from weekly BFI score at baseline (Visit 4) to the mean BFI score of Week 9 ─ 12 of the double-blind doseescalation/ treatment phase
    3. Absolute and relative changes from baseline (Visit 4) in BFI score at the end of each week (at each visit) during the double-blind doseescalation/ treatment phase and the extension phase
    4. Proportion of subjects ("responders") with a decrease in BFI score of ≥12 as compared with baseline (Visit 4) at the end of Week 12 (Visit 11) of the double-blind dose-escalation / treatment phase
    5. Number of weeks with a decrease in BFI score of ≥12 as compared with baseline (Visit 4) during the double-blind dose-escalation / treatment phase
    6. Proportion of subjects ("additional responders") with a decrease in BFI score of ≥12 in ≥9 weeks out of the 12-week double-blind doseescalation / treatment phase as compared with baseline (Visit 4)
    7. Absolute and relative changes from baseline (Visit 4) in mean
    numbers of BMs, SBMs, and CSBMs per week during the last 4 weeks (Week 9 to 12) of the double-blind dose-escalation / treatment phase
    8. Absolute and relative changes from baseline (Visit 4) in mean daily number of BMs, SBMs, and CSBMs at each week during the double-blind dose-escalation / treatment phase and the extension phase
    9. Proportion of subjects with ≥3 CSBMs per week during the last 4
    weeks (Week 9 to 12) of the double-blind dose-escalation / treatment phase
    10. Number of weeks with ≥3 CSBMs during the double-blind doseescalation / treatment phase and the extension phase
    11. Number of weeks with an increase of at least 1 CSBM over baseline (Visit 4) during the double-blind dose-escalation / treatment phase and the extension phase
    12. Absolute and relative change from baseline (Visit 4) in proportion of type 1 and 2 defecations per week according to BSFS at the end of Week 12 (Visit 11)
    13. Absolute and relative change from baseline (Visit 4) in each item of the Symptoms of Defecation Score to Week 12 (Visit 11)
    14. Absolute and relative change from baseline (Visit 4) in PAC-SYM at the end of each 2-week escalation step as well as at the end of the double-blind dose-escalation / treatment phase and the extension phase
    15. Absolute and relative change from baseline (Visit 4) in PAC-QOL at the end of each 2-week escalation step as well as at the end of the double-blind dose-escalation / treatment phase and the extension phase
    16. Mean number of days with laxative rescue medication use per week during the single-blind Naloxone HCl PR Placebo run-in phase, the double-blind dose-escalation / treatment phase and the extension phase
    17. Percentage of days with laxative use during the single-blind
    Naloxone HCl PR Placebo run-in phase, the double-blind dose-escalation / treatment phase, and the extension phase
    18. Differences in recurrence of OIC-related symptoms using BFI;
    number of BMs, SBMs, and CSBMs; BSFS, Symptoms of Defecation Score and laxative use between abrupt and tapered cessation of Naloxone HCl PR /Naloxone HCl PR Placebo during the extension phase
    19. Correlation between opioid total daily dose (TDD) (morphine
    equivalents) and individually determined final IMP dose at Week 12
    of double-blind dose-escalation / treatment phase
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end points are evaluated at the end of the trial.
    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 No
    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
    Dose-escalation to determine a dosing regimen in order to reveal an
    optimal dose of Naloxone HCL PR tablets administered once daily for the treatment of opioid-induced constipation.
    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 Yes
    E.8.1.7.1Other trial design description
    Dose-escalation to determine a dosing regimen of Naloxone HCL PR
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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 years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days15
    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.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 106
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 306
    F.4.2.2In the whole clinical trial 306
    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)
    After the end of the trial, the subjects will be treated according to local
    standard practice.
    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 Decision2013-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-01
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