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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-002145-21
    Sponsor's Protocol Code Number:2007003
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-08-27
    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 number2007-002145-21
    A.3Full title of the trial
    A Phase II, Randomized, Placebo-controlled Study of ATI-7505 in Patients with Chronic Idiopathic Constipation
    A.4.1Sponsor's protocol code number2007003
    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 SponsorProcter & Gamble Pharmaceuticals
    B.1.3.4CountryUnited Kingdom
    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 nameATI-7505
    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 INNnot assigned yet
    D.3.9.1CAS number 860174-12-5
    D.3.9.2Current sponsor codeATI-7505 dihydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 typeactive substance is synthetic origin
    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 nameATI-7505
    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 INNnot assigned yet
    D.3.9.1CAS number 860174-12-5
    D.3.9.2Current sponsor codeATI-7505 dihydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 typeactive substance is synthetic origin
    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
    Chronic Idiopathic Constipation
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10063582
    E.1.2Term Constipation chronic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of multiple dose levels of ATI-7505 in patients with chronic idiopathic constipation
    E.2.2Secondary objectives of the trial
    To determine the safety and tolerability of ATI-7505
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria at Screening:

    Patients are eligible to participate in the study if they:

    a. are willing and able to provide written informed consent;
    b. are male or female between 18 and 75 years of age, inclusive, at screening;
    c. had constipation symptom onset at least 6 months ago;
    d. have for the last 3 months prior to randomization, on average, fewer than 3 bowel
    movements per week along with one or more of the following symptoms of constipation (Drossman 2006):
    • Straining with ≥25% of defecations;
    • Lumpy or hard stools with ≥25% of defecations;
    • Sensation of incomplete evacuation ≥25% of defecations; or
    • Sensation of anorectal obstruction/blockage for ≥25 % of defecations;
    e. had a negative colonoscopy or air contrast barium enema (the latter in conjuction with flexible sigmoidoscopy) to exclude organic (mucosal) disease of the colon (along with the rectum and anus) within the past 5 years with unchanged constipation symptoms and no current suspicion of organic (mucosal) pathology. A negative result on computed tomographic (CT) colography, if already done within the past 5 years, with unchanged constipation symptoms and with no current suspicion of organic (mucosal) pathology is also acceptable.
    Note: Run-in period may not start until at least 7 days after any of the colon imaging
    procedures.
    f. are female and are (as documented by verbally offered medical history):
    • postmenopausal (at least 1 year without spontaneous menses), or
    • surgically sterile (tubal ligation or hysterectomy), or
    • using highly effective (ICH 1997) contraception (eg, oral, intramuscular, or implanted hormonal contraception [at least 3 months prior to enrollment], sexual partner with nonreversed vasectomy [with azoospermia in 2 tests], 2 independent barrier methods [ie, a combination of 2 of the following methods: condom, diaphragm, or properly applied spermicide], or intra-uterine device). Women who are using contraception will be required to have a pregnancy test (urine) at the Screening, Baseline/Day 1, Day 15, and Day 30 visits.
    g. have had no changes in dose of selective serotonin reuptake inhibitor (SSRI) drugs (if they are taking them) in the 30 days prior to screening and are not planning such changes for the duration of the study;
    h. have had no significant changes in diet, fiber intake, fluid intake, or physical activity in the 2 months prior to screening and are not planning such changes for the duration of the study;
    i. are able to refrain from use of medications known to treat constipation or associated symptoms throughout the study except rescue medication as noted in protocol section 3.6.10.

    Inclusion Criteria at Randomization

    Patients are eligible for randomization to a treatment group in the study if they:

    a. have, on average, fewer than 3 bowel movements per week during the 2-week run-in period;
    b. have at least 1 bowel movement each week of the 2-week run-in period;
    c. have had no significant changes in diet, fiber intake, fluid intake, or physical activity level during the 2-week run-in period;
    d. have been at least 70% compliant during the 2-week run-in period with electronic patient reported outcome (ePRO) e-diary entries (at least 10 out of 14 e-diary entries); and
    e. have not missed more than 3 consecutive days of e-diary entries.
    E.4Principal exclusion criteria
    Patients will be excluded from admission to the 2-week run-in period or randomization to a treatment group if they have/are:
    a. a history of transabdominal surgery within the 6 months prior to screening;
    b. presence or suspected presence of unstable coronary artery disease, organic gastrointestinal disease, or collagen vascular disease within the 6 months prior to screening;
    c. any alarm symptoms including uninvestigated anemia, rectal bleeding, weight loss, or unresolved fever within the 6 months prior to screening;
    d. taking prohibited medications specified in Section 3.3 within 30 days prior to screening or planning to take prohibited medications at any time during the study except laxatives used only as rescue medication consistent with protocol section 3.6.10;
    e. participating in another drug or medical device study or use of any investigational drug within 30 days before dosing or planning to use prior to study completion;
    f. at screening, a QT interval corrected for heart rate using Bazett’s correction formula (QTcB) >440 msec as calculated by the Investigator. The ECG core laboratory will also determine the QTcB and the QT interval corrected for heart rate using Fridericia’s correction formula (QTcF). If either QTcB or QTcF reported by the ECG core laboratory exceeds 440 msec, the patient will not be randomized;
    g. at the baseline visit, a QTcB >440 msec as calculated by the Investigator;
    h. a clinically significant abnormal 12-lead ECG with evidence of acute or recent myocardial infarction or ischemia, rhythm disturbance, or conduction abnormality other than first degree AV block;
    i. a family history of sudden death at age <40 years;
    j. a personal or family history of long QT syndrome;
    k. evidence of current or recent alcohol or drug abuse within the 6 months prior to screening;
    l. a serum potassium, magnesium, or calcium value outside the laboratory reference range at screening;
    m. a serum aspartate transaminase (AST), alanine transaminase (ALT), or gamma glutamyl transferase (GGT) ≥3 times the upper limit of the normal laboratory reference range at screening or baseline, or a bilirubin value ≥2 times the upper limit of the normal laboratory reference range at screening;
    n. a fasting blood glucose >2 times the upper limit of normal laboratory reference range at screening;
    o. an abnormal thyroid stimulating hormone (TSH) value at screening, unless the free T4 value is normal;
    Note: Stable doses of levothyroxine will be allowed during the study provided the doses have been stable (ie, have not changed) for at least 30 days prior to screening and are not expected to change for the duration of the study.
    p. any laboratory value(s) outside the laboratory reference range at screening that are considered to be clinically significant by the Investigator;
    q. more than a rare occurrence (more than 1 per month) of loose stools without the use of laxatives;
    r. a history of or evidence of current laxative abuse;
    s. experiencing continuous abdominal pain for more than 4 hours before bowel movements;
    t. taking any herbal remedies, herbal laxatives, or laxative teas;
    u. taking fiber supplementation or probiotics at dosages that have not been stable for at least the 2 months prior to screening or that are not expected to remain unchanged during the study;
    Note: Fiber supplementation and probiotics at doses that have not changed in the 2 months prior to screening and are not expected to change during the study are allowed.
    v. taken or planning to take protocol-specified rescue medication during the 48 hours
    immediately preceding the first dose of study drug (evening of Day 1);
    w. a known history or suspicion of autonomic dyssynergic defecation;
    x. a positive pregnancy test or are nursing or planning a pregnancy during screening, run-in, active treatment, or the follow-up period; or
    y. a history or presence, upon clinical evaluation, of any illness or condition that might impact the safety of study drug administration or evaluability of drug effect based on the Investigator’s discretion.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the total number of spontaneous bowel movements (SBM) during the first 7 days after randomization. For patients with 4 to 6 days of data recorded during the first week of treatment, the primary efficacy endpoint will be the imputed total number of SBMs over 7 days. For patients with less than 4 days of data recorded during the first week of treatment, the primary efficacy endpoint will be set to ‘missing’. This endpoint will be collected using a daily PRO assessment administered electronically via telephone.
    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 Yes
    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 concerned7
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA17
    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
    The study is considered terminated upon completion of all patient treatments and evaluations.
    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 months0
    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 months6
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 102
    F.4.2.2In the whole clinical trial 400
    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 are no plans for treatment or care beyond standard medical treatments of the respective condition.
    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 Decision2007-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-07-03
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