tacrolimus suppositories versus beclomethason suppostories for the treatment of proctitis refractory to local 5-ASA.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 113

Inclusion Criteria

Endoscopically or histologically proven ulcerative proctitis at least 3 months before randomization.
Proctitis is defined as: disease activity to 20 cm beyond the anal verge.
Refractory proctitis defined as a failure to at least the use of 5-asa suppositories of a maximum of 1 gram for at least 28 days and recurrent proctitis is defined as relapse within 3 months after stopping of local adequate 5-asa treatment.
Endoscopy may have been performed up to 3 weeks before screening, if the endoscopy was well documented and biopsies were taken.
Age: 18-70 years and written informed consent.
Permitted concomitant therapy: oral aminosalicylates, azathioprine, 6-mercatopurine and methotrexate at stable dose for 12 weeks

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Use of enemas: 5-asa or beclamethason
Infliximab or other anti TNF treatment within 12 weeks prior to randomization
Teatment with tacrolimus prior to randomization
Treatment with any investigational drug within 12 weeks of randomization
Abnormal renal function
Pre-existent leucopenia or thrombopenia
- Neutrophil count 1,800/mm3
- Platelets 90,000/mm3
Liverfunction tests abnormalities (>2 ULN).
Other significant medical illness that might interfere with this study: current malignancy
Immunodeficiency syndromes.
Any known pre-existing medical condition that could interfere with the patient's
participation in and completion of the study such as: - Preexisting psychiatric condition, especially depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded. Severe depression would include the
following: (a) subjects who have been hospitalized for depression, (b) subjects who have received electroconvulsive therapy for depression, or (c) subjects whose depression has resulted in a prolonged absence of work and/or significant disruption of daily functions. Subjects with a history of mild depression may be considered for entry into the protocol provided that a pretreatment assessment of the subject’s mental status supports that the
subject is clinically stable and that there is ongoing evaluation of the patient’s mental status during the study
- CNS trauma or active seizure disorders requiring medication
- Significant cardiovascular dysfunction within the past 6 months (e.g.,angina, congestive heart failure, recent myocardial infarction, severehypertension or significant arrhythmia).
- Poorly controlled diabetes mellitus
- Significant pulmonary dysfunction/ chronic disease (e.g., chronic obstructive pulmonary disease)
- Renal insufficiency (elevated serum creatinin)
Pregnancy, Lactation
Substance abuse, such as alcohol (80 gm/day), I.V. drugs and inhaled drugs. If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 years. Subjects receiving methadone within the past 2 years are also excluded ?Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study.
Positive stool culture for enteric pathogens

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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