Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis
Photopill
Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients With Ulcerative Proctitis
1 other identifier
interventional
8
1 country
1
Brief Summary
Low Level Light therapy (LLLT) has been used for tissue healing in many mucosal diseases that involve wounds, ulcers and inflammation, oral chemotherapy-induced mucositis in particular. Likewise IBD is characterized by chronic tissue inflammation, tissue damage and ulcerations in various extents. Therefore we hypothesize that LLLT might be effective in treating IBD and the Photopill capsule was developed for this purpose. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 18, 2013
CompletedFirst Posted
Study publicly available on registry
April 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJune 23, 2015
June 1, 2015
2.3 years
April 18, 2013
June 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events
Any adverse events reported by subjects
day 0-42
Secondary Outcomes (3)
Inflammatory markers
day 0,14,28,42
Clinical Questionnaires
day 0,14,28,42
Mucosal appearance at sigmoidoscopy
week 0,14,28.42
Study Arms (1)
Photopill treatment
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Diagnosed with Ulcerative Proctitis (Mayo grade 1/2)
You may not qualify if:
- Symptomatic hemorrhoids
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Academic Medical Center
Amsterdam, North Holland, 1105 AZ, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geert R D'Haens, MD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 18, 2013
First Posted
April 23, 2013
Study Start
January 1, 2013
Primary Completion
May 1, 2015
Study Completion
June 1, 2015
Last Updated
June 23, 2015
Record last verified: 2015-06