Colitis, UlcerativePhase 1NCT02745678
Localized Therapeutics for the Treatment of Gastrointestinal Disorders II
A Phase 1 study testing Thermosensitive gel rectal formulation in people with Colitis, Ulcerative, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to investigate a novel thermosensitive topical gel formulation for the treatment of inflammatory bowel disease (IBD), specifically ulcerative colitis. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Thermosensitive gel rectal formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Nov 2017
- Phase
- Phase 1
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Voluntarily sign written informed consent.
- Male or non-pregnant and non-lactating females at least 8 years of age.
- Confirmed diagnosis of active, mild to moderate ulcerative proctitis or proctosigmoiditis extending no further than 40cm from the anal verge. Typically, baseline Mayo Disease Activity Index (MMDAI) score between 5 and 10 (indicating mild to moderate disease).
Who cannot join
- Known infection with Clostridium difficile (C. difficile) and/or other enteric pathogens
- 5-aminosalicylic acid (5-ASA) intolerance
- Current or recent (3 weeks) oral or rectal steroids
- History of thiopurine or Anti-tumor necrosis factor (Anti-TNF) alpha treatment for colitis
- Abnormal creatinine
- Previous small bowel or colonic resection,
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- Anal sphincter incompetence,
- Current smokers.
- History or current diagnosis of Crohn's disease or indeterminate colitis.
- History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic or known gallbladder disease.
- Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease.
- Hemoglobin levels < 7.5 g/dL.
- History of sclerosing cholangitis, cirrhosis, or hepatic impairment
- Pregnant or at risk of pregnancy.
- Some medications to treat UC are prohibited during participation in the study, including laxatives and anti-diarrhea medications; oral 5-ASA agents and daily fiber supplements are allowed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate a novel thermosensitive topical gel formulation for the treatment of inflammatory bowel disease (IBD), specifically ulcerative colitis.
- Conditions
- Colitis, Ulcerative
- Being tested
- Thermosensitive gel rectal formulation
- Keywords
- Enema, Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermosensitive gel rectal formulationDrug
| Study group | Role | What they receive |
|---|---|---|
| Thermosensitive gel formulation | Experimental | Thermosensitive gel rectal formulation. Receives: Drug: Thermosensitive gel rectal formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of a new formulation in patients with mild-to-moderately-active Ulcerative Colitis using the Mayo Disease Activity Index (MMDAI)
Using Modified Mayo Score
Measured: Between 4-6 weeks post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidhartha R Sinha, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745678
- Sponsor's protocol ID
- IRB- 34970
- Status last verified
- Aug 2018
- First submitted
- 23 Mar 2016
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localized Therapeutics for the Treatment of Gastrointestinal Disorders II
- ClinicalTrials.gov ID
- NCT02745678
- Acronym / sponsor ID
- IRB- 34970
- Conditions
- Colitis, Ulcerative
- Keywords
- Enema, Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 20 Apr 2016 (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.
The purpose of this study is to investigate a novel thermosensitive topical gel formulation for the treatment of inflammatory bowel disease (IBD), specifically ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thermosensitive gel formulation | Experimental | Drug: Thermosensitive gel rectal formulationThermosensitive gel rectal formulation. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Voluntarily sign written informed consent.
- Male or non-pregnant and non-lactating females at least 8 years of age.
- Confirmed diagnosis of active, mild to moderate ulcerative proctitis or proctosigmoiditis extending no further than 40cm from the anal verge. Typically, baseline Mayo Disease Activity Index (MMDAI) score between 5 and 10 (indicating mild to moderate disease).
Key exclusion criteria (15 listed)
- Known infection with Clostridium difficile (C. difficile) and/or other enteric pathogens
- 5-aminosalicylic acid (5-ASA) intolerance
- Current or recent (3 weeks) oral or rectal steroids
- History of thiopurine or Anti-tumor necrosis factor (Anti-TNF) alpha treatment for colitis
- Abnormal creatinine
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 |
|---|---|---|
| Thermosensitive gel rectal formulation | Drug | Thermosensitive gel formulation |
Primary outcome
Safety and efficacy of a new formulation in patients with mild-to-moderately-active Ulcerative Colitis using the Mayo Disease Activity Index (MMDAI)
Time frame: Between 4-6 weeks post-administration
Using Modified Mayo Score
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 16 Aug 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thermosensitive gel rectal formulation in people with Colitis, Ulcerative, run by Stanford University at 1 site in United States.
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 3 inclusion and 15 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 16 Aug 2018. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety and efficacy of a new formulation in patients with mild-to-moderately-active Ulcerative Colitis using the Mayo Disease Activity Index (MMDAI) (time frame: Between 4-6 weeks post-administration). 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 16 Aug 2018.