Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02790138 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis
A Phase 4 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 4
- Development phase
- 102
- Enrollment target
NCT02790138: Completed Phase 4 study, sponsored by Takeda.
NCT02790138 is a Phase 4 study that has completed, run by Takeda. The registered enrollment target is 102 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02790138, a Phase 4 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 102 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the efficacy of vedolizumab intravenous (IV) and placebo in terms of the percentage of participants with chronic or recurrent pouchitis achieving clinically relevant remission.
Primary Outcome
Clinically relevant remission is defined as modified Pouchitis Disease Activity Index (mPDAI) score \<5 and a reduction of mPDAI score by ≥2 points from Baseline. The 12-point mPDAI score is calculated as a sum of from two 6-point subscales, where 0 = best and 12 = worst.: 1) Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=three or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=Non
Interventions
- DRUG Vedolizumab
- DRUG Ciprofloxacin
- DRUG Vedolizumab Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2016-10-12 |
| Est. Completion | 2021-02-02 |
| Phase | Phase 4 |
What the finished NCT02790138 record still lists
NCT02790138 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Vedolizumab is the first listed.
NCT02790138 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02790138 about?
NCT02790138 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis". The purpose of this study is to compare the efficacy of vedolizumab intravenous (IV) and placebo in terms of the percentage of participants with chronic or recurrent pouchitis achieving clinically relevant remission.
What is the current status of trial NCT02790138?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 102 participants. The study started on 2016-10-12. Estimated completion is 2021-02-02.
What interventions are being tested in trial NCT02790138?
The interventions under investigation include: Vedolizumab (DRUG), Ciprofloxacin (DRUG), Vedolizumab Placebo (DRUG).
Who is sponsoring clinical trial NCT02790138?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02790138's enrollment target sits among peer trials
102 764th of 2000 higher than 1,235 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03704662 · 102 participants · NA
Preoperative Fractionated Radiation Therapy Versus Stereotactic Body Radiation Therapy for Resectable or Borderline Resectable, or Locally Advanced Type A Pancreatic Adenocarcinoma
- NCT04174742 · 102 participants
Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer
- NCT04275362 · 102 participants
Gait Analysis of a Lateral-Pivot Design Total Knee Replacement
- NCT04541082 · 102 participants · Phase 1
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI