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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2005-001655-38-ES |
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Date of registration:
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30/03/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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N/A
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Scientific title:
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N/A |
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Date of first enrolment:
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01/09/2005 |
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Target sample size:
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336 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001655-38 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Belgium
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Germany
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Greece
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Portugal
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Romania
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Russian Federation
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Spain
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Turkey
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Contacts
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Name:
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Medical Department
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Address:
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Via Sette Santi 1.
50131
Forencia
Italy |
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Telephone:
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39555680336NA |
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Email:
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MNotari@menarini.it |
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Affiliation:
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Menarini IFR - International Division |
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Name:
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Medical Department
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Address:
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Via Sette Santi 1.
50131
Forencia
Italy |
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Telephone:
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39555680336NA |
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Email:
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MNotari@menarini.it |
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Affiliation:
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Menarini IFR - International Division |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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MedDRA version: 14.1
Level: PT
Classification code 10023003
Term: Irritable bowel syndrome
System Organ Class: 10017947 - Gastrointestinal disorders
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Intervention(s)
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Trade Name: Spasmoctyl
Product Name: Spasmoctyl
Pharmaceutical Form: Pill
INN or Proposed INN: OTILONIUM BROMIDE
CAS Number: 26095-59-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Pill
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s):
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Secondary Objective:
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Main Objective:
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Secondary ID(s)
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2005-001655-38-BE
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MeFi/04/OBR-IBS/001
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Source(s) of Monetary Support
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Menarini IFR - International Division
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Ethics review
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Status: Approved
Approval date:
Contact:
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