Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis
NCT ID: NCT01837615
Last Updated: 2015-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
8 participants
INTERVENTIONAL
2013-01-31
2015-06-30
Brief Summary
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An open-label, interventional, clinical trial was designed for assessment of the safety and feasibilty of the Photopill capsule treatment in patients with mild to moderate Ulcerative Proctitis.
Primary endpoints being: safety reflected by the number and severity of adverse events and mucosal appearance at sigmoidoscopies day 14, day 28, day 42 compared to baseline condition.
Furthermore clinical and biochemical parameters are monitored during the study.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Photopill treatment
Photopill treatment
Interventions
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Photopill treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant or lactating females
* Patients that have used any experimental treatment within 8 weeks prior to Day 0
* Patient that have used any biologics therapies or immunomodulation agents and/or steroids 4 weeks prior to Day 0
* Rectal therapy 2 weeks prior to Day 0
18 Years
65 Years
ALL
No
Sponsors
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Photopill Medical Ltd
UNKNOWN
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Hanke Brandse
MD
Principal Investigators
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Geert R D'Haens, MD
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
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Academic Medical Center
Amsterdam, North Holland, Netherlands
Countries
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Other Identifiers
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NL39583.018.12
Identifier Type: -
Identifier Source: org_study_id
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