Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis (Photopill)

June 22, 2015 updated by: Hanke Brandse, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients With Ulcerative Proctitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Academic Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with Ulcerative Proctitis (Mayo grade 1/2)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Photopill treatment
Device: Photopill treatment
Other Names:
  • Photopill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: day 0-42
Any adverse events reported by subjects
day 0-42

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory markers
Time Frame: day 0,14,28,42
serum CRP, serum Hb/Ht, fecal Calprotectin
day 0,14,28,42
Clinical Questionnaires
Time Frame: day 0,14,28,42
Simple Clinical Colitis Activity Index Partial Mayo score
day 0,14,28,42
Mucosal appearance at sigmoidoscopy
Time Frame: week 0,14,28.42
endoscopic disease activity Mayo score and possible damage by device
week 0,14,28.42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Photopill Medical Ltd

Investigators

  • Principal Investigator: Geert R D'Haens, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

April 18, 2013

First Submitted That Met QC Criteria

April 18, 2013

First Posted (ESTIMATE)

April 23, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL39583.018.12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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