NCT01630746

Brief Summary

The purpose of this study is to evaluate the acid-inhibitory and dose-response efficacy of TAK-438 (20 mg, 40 mg) in patients with PPI-resistant erosive esophagitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

February 10, 2014

Status Verified

February 1, 2014

Enrollment Period

1.2 years

First QC Date

June 26, 2012

Last Update Submit

February 7, 2014

Conditions

Erosive Esophagitis

Outcome Measures

Primary Outcomes (1)

  • Time-course of changes in 24-hour gastroesophageal pH

    Gastric and esophageal pH4 HTR (pH 4 Holding Time Ratio) will be calculated based on 24-hour gastroesophageal pH monitoring.

    Week 8

Study Arms (2)

TAK-438 20 mg/day

EXPERIMENTAL
Drug: TAK-438

TAK-438 40 mg/day

EXPERIMENTAL
Drug: TAK-438

Interventions

TAK-438DRUG
TAK-438 20 mg/day

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The participant has been treated with standard-dose or higher-than-standard-dose PPI until immediately before the start of the Observation Phase.
  • Outpatient (in principle)
  • At the endoscopy scheduled for the Observation Phase (Visit 2), the participant must have endoscopically confirmed reflux esophagitis of Grade A to D, as defined by the LA classification grading system, which remains insufficiently controlled with standard-dose or higher-than-standard-dose PPI therapy.
  • The participant showed good compliance to the study medication in the Observation Phase (compliance rate 80% or more).

You may not qualify if:

  • Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included.
  • Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis \[excluding Schatzki's ring\], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy)
  • Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating) at the start of the Observation Phase (Visit 1) or at endoscopy during the Observation Phase (Visit 2) . However, participants with gastric or duodenal erosions are allowed to be included.
  • Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Gifu, Gifu, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Hitachi-shi, Ibaraki, Japan

Location

Unknown Facility

Kochi, Kochi, Japan

Location

Unknown Facility

Sendai, Miyagi, Japan

Location

Unknown Facility

Osaka, Osaka, Japan

Location

Unknown Facility

Saga, Saga-ken, Japan

Location

Unknown Facility

Izumo-shi, Shimane, Japan

Location

Unknown Facility

Hamamatsu, Shizuoka, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, Japan

Location

Unknown Facility

Mitaka-shi, Tokyo, Japan

Location

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine

Study Officials

  • Medical Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2012

First Posted

June 28, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

February 10, 2014

Record last verified: 2014-02

Locations

JP(11)