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

Ulcerative Colitis Clinical Trial

— Photopill  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837615
• Other study ID #: NL39583.018.12
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2013
• Last updated: June 22, 2015
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Proctitis
• Ulcer
• Ulcerative Colitis

Intervention

Device:
• Photopill treatment

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	North Holland

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Photopill Medical Ltd

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Any adverse events reported by subjects	day 0-42	Yes
Secondary	Inflammatory markers	serum CRP, serum Hb/Ht, fecal Calprotectin	day 0,14,28,42	No
Secondary	Clinical Questionnaires	Simple Clinical Colitis Activity Index Partial Mayo score	day 0,14,28,42	No
Secondary	Mucosal appearance at sigmoidoscopy	endoscopic disease activity Mayo score and possible damage by device	week 0,14,28.42	Yes