A Phase 3 Study to Evaluate the Safety and Efficacy of TAK-390MR (30 mg QD and 60 mg QD) Compared to Placebo in Maintenance of Healing in Subjects with Healed Erosive Esophagitis
- Conditions
- Erosive esophagitis
- Registration Number
- EUCTR2006-000419-90-HU
- Lead Sponsor
- TAP Pharmaceutical Products Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
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. Subjects must have successfully completed the Phase 3 Study T EE04 084 or T EE04 085; and have endoscopically proven healed EE. .
3. All female subjects must 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.
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
1. Any condition that may require surgery during the course of the study.
2. Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate throughout the study.
3. Chronic use (>12 doses per month) of non-steroidal anti-inflammatory drugs (NSAIDs) including COX 2 NSAIDs throughout the study, however, low dose aspirin up to 325 mg per day is allowed.
4. Use of antacids [except for study supplied Gelusil (U.S. sites) or a similar equivalent approved antacid (ex U.S. sites)] throughout the study.
5. Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
6. Use of misoprostil or prokinetics throughout the study.
7. Need for continuous anticoagulant therapy.
8. Evidence of uncontrolled systemic disease.
9. Subject who, in the opinion of the investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.
10. Subjects who have participated in either maintenance study (T-EE04-086 or T EE04 087).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): The percentage of subjects who maintained complete healing of EE over 6 months as assessed by endoscopy.;Main Objective: 1. To assess the efficacy in maintenance of healing of TAK 390MR (30 mg QD and 60 mg QD) compared to placebo in subjects with healed EE.<br>2. To assess the safety of TAK-390MR (30 mg QD and 60 mg QD) compared to placebo in subjects with healed EE.<br>;Secondary Objective: 1. To assess the efficacy of TAK-390MR (30 mg QD and 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 6 months through the collection of daily electronic diaries in subjects with healed EE.<br>2. To assess the efficacy of TAK-390MR (30 mg QD and 60 mg QD) compared to placebo in relief of nighttime heartburn over 6 months through the collection of daily electronic diaries in subjects with healed EE.<br>
- Secondary Outcome Measures
Name Time Method