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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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19 March 2012 |
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Main ID: |
EUCTR2009-015136-14-BE |
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Date of registration:
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12/10/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Modified release metronidazole for the treatment of pouchitis after colectomy with ileo-anal pouch anastomosis for ulcerative colitis: a pharmacokinetic study
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Scientific title:
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Modified release metronidazole for the treatment of pouchitis after colectomy with ileo-anal pouch anastomosis for ulcerative colitis: a pharmacokinetic study |
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Date of first enrolment:
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20/11/2009 |
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Target sample size:
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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:2009-015136-14 |
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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: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Cummulative design
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Belgium
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Males or females aged > 18 years.
2. Subjects with IPAA (ileo-anal pouch anastomosis) who have a functioning pouch without
ileostomy for at least 6 months.
3. Subjects with a PDAI score of >7 (Appendix 3).
4. Subjects with acute active pouchitis or chronic active pouchitis diagnosed by endoscopy with biopsy
5. Subjects willing and able to give written informed consent to participate in the study.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Evidence of ongoing or recent (within 14 days) gastrointestinal infection or positive stool culture for enteric pathogens or C. difficile toxin positivity
2. Subjects with a pouch related fistula or stenosis of pouch outlet
3. Female subjects who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control
4. Subjects with documented hypersensitivity to nitro-imidazol antibiotics
5. Subjects who have taken antibiotics within 3 days of the study
6. Subjects who participated to the trial in the previous 14 days
7. Subjects who have received metronidazole in the previous 14 days.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Pouchitis
MedDRA version: 12.0
Level: LLT
Classification code 10036463
Term: Pouchitis
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Intervention(s)
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Product Name: Metronidazole capsule 50 mg
Product Code: FP-110
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Metronidazole
CAS Number: 44-348-1
Current Sponsor code: Fp-110
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Flagyl
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Metronidazole
CAS Number: 443-38-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
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Primary Outcome(s)
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Primary end point(s): Pharmacokinetics of the formulations: The AUC of the modified release formulations, calculated on equivalent dose, must be significantly lower compared to the immediate release formulation of metronidazole
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Secondary Objective: Exploratory, safety and efficacy of the treatment will also be evaluated to see whether change in systemic exposure reduces side effects and whether the modified release formulation shows clinical benefit to the subjects.
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Main Objective: To investigate the pharmacokinetics of two dosages of a modified release formulation of metronidazole in subjects with active acute or chronic pouchitis and compare it to the current standard immediate release formulation of metronidazole (Flagyl 500 mg).
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Secondary ID(s)
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FP-0110-201
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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