Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics
Public ClinicalTrials.gov record NCT02525523. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Topical Alicaforsen Enema in Subjects With Active, Chronic, Antibiotic Refractory Primary Idiopathic Pouchitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A Phase III, multi-centre, double-blind randomised controlled trial in subjects with chronic antibiotic refractory pouchitis. Subjects will undertake a \<2 week screening period to provide baseline data and be assessed for eligibility. At the Baseline visit (Day 1) eligible subjects will be randomised on a 1:1 basis to either a) 240 mg alicaforsen enema or b) matching placebo. Study drug will be administered once nightly (on going to bed) up to and including week 6. Following the Day 1 Visit, subjects will return to the clinic for safety and efficacy assessments at Week 3, 6, 10, 18 and 26. Subjects may receive certain permitted medications as per Entry Criteria, which must remain at stable doses throughout the trial. Introduction of any new medication for pouchitis, or a dose change to an existing concomitant medication for pouchitis, other than those detailed in the protocol, will not be permitted. Clinical symptoms associated with pouchitis will be recorded daily by the patient in a diary card. Subjects will undergo endoscopic examination of their pouch (during Screening, and at Weeks 6 and 10). Where technically feasible, each endoscopy will provide at least one biopsy sample for histopathology. In addition to endoscopic, histopathologic and symptomatic assessments, Quality of Life will be assessed. Bloods for routine assessment, including haematology and biochemistry will be taken. Bloods and stool samples will be collected to evaluate relevant biomarkers.
Study identification
- NCT ID
- NCT02525523
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 138 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2, 2015
- Primary completion
- Jul 8, 2018
- Completion
- Oct 28, 2018
- Last update posted
- Feb 24, 2020
2015 – 2018
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site Reference ID/Investigator# 1008 | La Jolla | California | 92037 | — |
| Site Reference ID/Investigator # 1005 | Los Angeles | California | 90048 | — |
| Site Reference ID/Investigator#1011 | Stanford | California | 94305 | — |
| Site Reference ID/Investigator#1012 | Atlanta | Georgia | 30322 | — |
| Site Reference ID/Investigator# 1010 | Chicago | Illinois | 60611 | — |
| Site Reference ID/Investigator# 1001 | Rochester | Minnesota | 55905 | — |
| Site Reference ID/Investigator# 1003 | Great Neck | New York | 11021 | — |
| Site Reference ID/Investigator# 1006 | New York | New York | 10016 | — |
| Site Reference ID/Investigator# 1009 | New York | New York | 10029 | — |
| Site Reference ID/Investigator# 1004 | Cleveland | Ohio | 44195 | — |
| Site Reference ID/Investigator# 1002 | Oklahoma City | Oklahoma | 73102 | — |
| Site Reference ID/Investigator# 1007 | Seattle | Washington | 98195-6424 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02525523, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 24, 2020 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02525523 live on ClinicalTrials.gov.