Ulcerative ColitisPhase 2PhotopillNCT01837615
Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis
A Phase 2 study testing Photopill treatment in people with Ulcerative Colitis and Proctitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis, Proctitis
- What is being tested?
- Photopill treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2013to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Ulcerative Proctitis (Mayo grade 1/2)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Center
Amsterdam, North Holland, 1105 AZ
About this study
Official title: 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.
Read more
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.
- Conditions
- Ulcerative Colitis, Proctitis
- Being tested
- Photopill treatment
- Keywords
- Ulcerative Colitis, Ulcerative Proctitis, Low Level Light Therapy, Safety, Efficacy
- Medical subject headings
- Colitis, Ulcerative, Proctitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photopill treatmentDevice
Also called Photopill
| Study group | Role | What they receive |
|---|---|---|
| Photopill treatment | Experimental | Not described Receives: Device: Photopill treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Any adverse events reported by subjects
Measured: day 0-42
Secondary outcomes (3)
Inflammatory markers
serum CRP, serum Hb/Ht, fecal Calprotectin
Measured: day 0,14,28,42
Clinical Questionnaires
Simple Clinical Colitis Activity Index Partial Mayo score
Measured: day 0,14,28,42
Mucosal appearance at sigmoidoscopy
endoscopic disease activity Mayo score and possible damage by device
Measured: week 0,14,28.42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Photopill Medical Ltd
- Responsible party
- Principal investigator, Hanke Brandse, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Geert R D'Haens, MD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837615
- Sponsor's protocol ID
- NL39583.018.12
- Acronym
- Photopill
- Status last verified
- Jun 2015
- First submitted
- 18 Apr 2013
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients With Ulcerative Proctitis
- ClinicalTrials.gov ID
- NCT01837615
- Acronym / sponsor ID
- Photopill / NL39583.018.12
- Conditions
- Ulcerative Colitis, Proctitis
- Keywords
- Ulcerative Colitis, Ulcerative Proctitis, Low Level Light Therapy, Safety, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Photopill Medical Ltd
- Study start
- Jan 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photopill treatment | Experimental | Device: Photopill treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with Ulcerative Proctitis (Mayo grade 1/2)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photopill treatmentAlso: Photopill | Device | Photopill treatment |
Primary outcome
Adverse events
Time frame: day 0-42
Any adverse events reported by subjects
3 secondary outcomes
Inflammatory markers
Time frame: day 0,14,28,42
Clinical Questionnaires
Time frame: day 0,14,28,42
Mucosal appearance at sigmoidoscopy
Time frame: week 0,14,28.42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert R D'Haens, MD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Photopill treatment in people with Ulcerative Colitis and Proctitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: day 0-42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.