A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60 mg QD and 90 mg QD) and an Active Comparator, Lansoprazole (30 mgQD) on Healing of Erosive Esophagitis

• Conditions: Erosive esophagitis

• Registration Number: EUCTR2005-001188-70-LT
• Lead Sponsor: TAP Pharmaceutical Products Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1950

Inclusion Criteria

1. Prior to any study-specific procedures being performed, the subject voluntarily signs an Informed Consent Form (ICF)/and any privacy statement/authorization form required by the region in which the subject is participating, after having its contents fully explained and all questions answered. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) must approve the ICFs.

2. Male or female subjects at least 18 years of age (and of legal age of consent).

3. All female subjects must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Day -1 and are using, and agree to continued use of, a double barrier method of birth control. Oral, injectable or patch contraceptives may be used as one method if the subject has been taking them for greater than three months duration at the Screening Visit. Subjects who have had a bilateral tubal ligation, hysterectomy or are post-menopausal (the absence of menses for 1-2 years with a Follicle-Stimulating Hormone [FSH] level ? 40 IU/L or absence of menses for > 2 years) are not required to use birth control.

4. Subject must have endoscopically confirmed EE as defined by the Los Angeles (LA) Classification Grading System (A-D).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject tests positive for H pylori based on the result of the CLO test. In the U.S. and Canada, a CLO test will only be performed for those subjects who test positive for H pylori by finger stick or serology at screening and have EE. For all other countries, a mandatory CLO test will be used at screening to determine subjects H pylori status

2. Use of prescription or non-prescription proton pump inhibitors (PPIs) during screening and throughout the study.

3. Use of prescription or non-prescription histamine (H2) receptor antagonists or sucralfate during screening and throughout the study.

4. Chronic use (>12 doses per month) of non-steroidal anti-inflammatory drugs (NSAIDs) including COX 2 NSAIDs within 30 days prior to the Screening Period and throughout the study, however, low dose aspirin up to 325 mg per day is allowed.

5. Use of antacids [except for study supplied Gelusil® (U.S. sites), or a similar equivalent approved antacid (ex U.S. sites)] during the Screening and Treatment Periods.

6. Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for the 4 weeks prior to dosing and throughout the study.

7. Subjects who cannot discontinue the use of the following medications prior to the first dose of study drug and throughout the study: misoprostol prokinetics

8. Need for continuous anticoagulant therapy.

9. Use of any investigational drug(s) within 30 days of Screening.

10. Cancer (except basal cell carcinoma of the skin) within 3 years prior to Screening.

11. Any condition that may require inpatient surgery during the course of the study.

12. Endoscopic Barrett’s esophagus and/or definite dysplastic changes in the esophagus. If any suspicious Barrett’s esophagus is seen during screening and the principal investigator is confident that the subject will be confirmed with Barrett’s, the subject may be automatically excluded. Otherwise, any suspicious Barrett’s esophagus seen during screening endoscopy will be biopsied and sent to a local pathology laboratory. Subjects may be randomized; however, the subject must be discontinued if the Screening biopsy is found to confirm Barrett’s and/or to have definite dysplastic changes. If the subject is discontinued, Final Visit procedures must be performed, with the exception of the endoscopy. Subjects with indeterminate dysplasia due to severe inflammation may be enrolled and rebiopsied at the next endoscopy.

13. Subjects with a history of dilatation of esophageal strictures, other than a Schatzki’s ring (a ring of mucosal tissue near the lower esophageal sphincter).

14. Subjects with active gastric or duodenal ulcers within 4 weeks of the first dose of study drug.

15. Co-existing diseases affecting the esophagus (eg, esophageal varices, scleroderma, viral, fungal infection or esophageal stricture), history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus.

16. Evidence of uncontrolled systemic disease.

17. Subject has abnormal laboratory values that suggest a clinically significant underlying disease or condition that may prevent the subject from entering the study or subject with the following lab abnormalities: Creatinine >1.5 mg/dL, Alanine Aminotransferase (ALT) and /or Aspartate Aminotransferase (AST) >2.5X the upper limits of normal, or Bilirubin >2.0 mg/dl with AST/ALT elevated above normal values.

18. Subject known

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of TAK 390MR (60 mg QD and 90 mg QD) compared to lansoprazole (30 mg QD) in healing EE over 8 weeks in subjects with endoscopically proven EE.<br>To assess the safety of TAK-390MR (60 mg QD and 90 mg QD) compared to Lansoprazole (30 mg QD) in subjects with endoscopically proven EE<br>;Secondary Objective: To assess the efficacy of TAK-390MR (60 mg QD and 90 mg QD) compared to lansoprazole (30 mg QD) in healing EE over 4 weeks in subjects with endoscopically proven EE.<br>To assess the efficacy of Tak-390MR (60 mg QD and 90 mg QD) compared to lansoprazole (30 mg QD) in healing EE over 8 weeks in subjects with endoscopically proven moderate to severe EE.<br>;Primary end point(s): The percentage of subjects who have complete healing of EE over 8 weeks as assessed by endoscopy.