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NCT01805791 · ClinicalTrials.gov registry record · Phase 3
A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis
A Phase 3 study, sponsored by Hutchison Medipharma Limited.
- Terminated
- Registry status
- Phase 3
- Development phase
- 201
- Enrollment target
NCT01805791 is a Phase 3 study that was terminated before completion, run by Hutchison Medipharma Limited. The registered enrollment target is 201 participants.
The verdict
NCT01805791, a Phase 3 study, was terminated before completion, sponsored by Hutchison Medipharma Limited.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 201 participants
- Enrollment target
Study Summary
A placebo controlled study of two doses of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent) as a concomitant medication. The objective is to evaluate the efficacy and safety of HMPL-004 with mesalamine (mesalamine treatment failures). Efficacy will be measured by a comparison of the proportion of patients in each treatment group attaining clinical remission at Week 8 as compared to placebo.
Interventions
- DRUG Placebo
- DRUG HMPL-004 1800 mg/day
- DRUG HMPL-004 2400 mg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01805791
The ClinicalTrials.gov registry entry for NCT01805791 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 201 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hutchison Medipharma Limited, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01805791 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01805791 about?
NCT01805791 is a clinical study titled "A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis". A placebo controlled study of two doses of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent) as a concomitant medication. The objective is to evaluate the efficacy and safety...
What is the current status of trial NCT01805791?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 201 participants. The study started on 2013-03. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01805791?
The interventions under investigation include: Placebo (DRUG), HMPL-004 1800 mg/day (DRUG), HMPL-004 2400 mg/day (DRUG).
Who is sponsoring clinical trial NCT01805791?
This trial is sponsored by Hutchison Medipharma Limited, which has 11 total clinical trials registered on ClinicalTrials.gov.
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