Ulcerative ColitisPhase 1NCT00038922
Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis
A Phase 1 study testing rhIL-11 in people with Ulcerative Colitis and Inflammatory Bowel Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
To explore the safety of orally delivered rhIL-11 in patients with mild to moderate left-sided ulcerative colitis. To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples and in colonic biopsy tissue samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Disease
- What is being tested?
- rhIL-11
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented, signed informed consent to participate in this study
- Age greater than or equal to 18 years
- Documented diagnosis of ulcerative colitis by standard clinical criteria, including endoscopy (either flexible sigmoidoscopy or colonoscopy, sufficient to define the proximal limit of disease) with biopsy
Who cannot join
- Crohn's disease
- Ulcerative proctitis
- Ulcerative colitis extending beyond the splenic flexure
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Safety and Exploratory Pharmacogenomic Study of Orally Administered Recombinant Human Interleukin Eleven (rhIL-11) in Patients With Mild to Moderate Left-Sided Ulcerative Colitis
To explore the safety of orally delivered rhIL-11 in patients with mild to moderate left-sided ulcerative colitis.
To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples and in colonic biopsy tissue samples.
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Disease
- Being tested
- rhIL-11
- Keywords
- Left-Sided, Ulcerative, Colitis
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases, Ulcer, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhIL-11Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2002 (estimated)
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.
- 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
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, MD, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038922
- Sponsor's protocol ID
- 3067K5-114
- Status last verified
- May 2006
- First submitted
- 5 Jun 2002
- Last updated
- 18 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Safety and Exploratory Pharmacogenomic Study of Orally Administered Recombinant Human Interleukin Eleven (rhIL-11) in Patients With Mild to Moderate Left-Sided Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00038922
- Acronym / sponsor ID
- 3067K5-114
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Disease
- Keywords
- Left-Sided, Ulcerative, Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- First posted
- 7 Jun 2002 (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.
To explore the safety of orally delivered rhIL-11 in patients with mild to moderate left-sided ulcerative colitis.
To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples and in colonic biopsy tissue samples.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented, signed informed consent to participate in this study
- Age greater than or equal to 18 years
- Documented diagnosis of ulcerative colitis by standard clinical criteria, including endoscopy (either flexible sigmoidoscopy or colonoscopy, sufficient to define the proximal limit of disease) with biopsy
Key exclusion criteria (3 listed)
- Crohn's disease
- Ulcerative proctitis
- Ulcerative colitis extending beyond the splenic flexure
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 |
|---|---|---|
| rhIL-11 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2006.
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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.
Medical Monitor, MD study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rhIL-11 in people with Ulcerative Colitis and Inflammatory Bowel Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 3 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: stopped early, as of the sponsor's last update on 18 May 2006. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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.
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 18 May 2006.