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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Collaborator:
Photopill Medical Ltd
Information provided by (Responsible Party):
Hanke Brandse, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01837615
First received: April 18, 2013
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Proctitis
Device: Photopill treatment
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients With Ulcerative Proctitis

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Adverse events [ Time Frame: day 0-42 ] [ Designated as safety issue: Yes ]
    Any adverse events reported by subjects


Secondary Outcome Measures:
  • Inflammatory markers [ Time Frame: day 0,14,28,42 ] [ Designated as safety issue: No ]
    serum CRP, serum Hb/Ht, fecal Calprotectin

  • Clinical Questionnaires [ Time Frame: day 0,14,28,42 ] [ Designated as safety issue: No ]
    Simple Clinical Colitis Activity Index Partial Mayo score

  • Mucosal appearance at sigmoidoscopy [ Time Frame: week 0,14,28.42 ] [ Designated as safety issue: Yes ]
    endoscopic disease activity Mayo score and possible damage by device


Estimated Enrollment: 8
Study Start Date: January 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Photopill treatment Device: Photopill treatment
Other Name: Photopill

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01837615

Contacts
Contact: Johannan F Brandse, MD +31205667805 j.f.brandse@amc.uva.nl

Locations
Netherlands
Academic Medical Center Recruiting
Amsterdam, North Holland, Netherlands, 1105 AZ
Contact: Johannan F Brandse, MD    +31205667805    j.f.brandse@amc.uva.nl   
Principal Investigator: Geert R D'Haens, MD, PhD         
Sub-Investigator: Johannan F Brandse, MD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Photopill Medical Ltd
Investigators
Principal Investigator: Geert R D'Haens, MD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

No publications provided

Responsible Party: Hanke Brandse, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01837615     History of Changes
Other Study ID Numbers: NL39583.018.12
Study First Received: April 18, 2013
Last Updated: April 22, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Ulcerative Colitis
Ulcerative Proctitis
Low Level Light Therapy
Safety
Efficacy

Additional relevant MeSH terms:
Proctitis
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 01, 2014