Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01452698
First received: September 16, 2011
Last updated: November 7, 2012
Last verified: November 2012

September 16, 2011
November 7, 2012
Not Provided
August 2012   (final data collection date for primary outcome measure)
Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
Endoscopic healing of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break <5 mm), Grade B (Mucosal break ≥5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the circumference) and Grade D (Mucosal break ≥75% of the circumference).
Same as current
Complete list of historical versions of study NCT01452698 on ClinicalTrials.gov Archive Site
  • Endoscopic Healing Rate Over 2 Weeks of Erosive Esophagitis [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
  • Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis
A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of TAK-438 (20 mg Once-Daily) Compared to AG-1749 (30mg Once-Daily) in Patients With Erosive Esophagitis

The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Erosive Esophagitis
  • Drug: TAK-438
    TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
  • Drug: Placebo

    Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks.

    For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks.

    Other Name: AG-1749
  • Drug: Lansoprazole

    Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

    For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks.

    Other Name: AG-1749
  • Drug: Placebo
    TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks.
  • Experimental: TAK-438 20 mg QD
    Interventions:
    • Drug: TAK-438
    • Drug: Placebo
  • Active Comparator: AG-1749 30 mg QD
    Interventions:
    • Drug: Lansoprazole
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
409
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. At Visit 1 (start of the observation period), the participant must have endoscopically confirmed erosive esophagitis of Grade A to D, as defined by the LA classification grading system, and the target number of participants who are clearly Grade C or D is 30% (120 participants) or more of the total participants.
  2. Outpatient (including inpatient for examination)

Exclusion Criteria:

  1. 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.
  2. 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)
  3. Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating) within 30 days prior to Visit 1 (start of the observation period). However, participants with gastric or duodenal erosions are allowed to be included.
  4. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01452698
TAK-438/CCT-002, U1111-1123-8356, JapicCTI-111607
No
Takeda
Takeda
Not Provided
Study Director: Senior Manager Takeda
Takeda
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP