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Clinical Trials/EUCTR2005-001190-10-EE
EUCTR2005-001190-10-EEActive, not recruitingNot Applicable

A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects with Healed Erosive Esophagitis

TAP Pharmaceutical Products Inc.0 sites1,950 target enrollmentStarted: December 1, 2005Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
1,950
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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. Subjects must have successfully completed the Phase 3 Study T-EE04-084; 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

Exclusion Criteria

  • •1. Any condition that may require surgery during the study.
  • •2. Use of prescription or non-prescription PPIs, histamine (H2) receptor antagonists or sucralfate throughout the study.
  • •3. Use of antacids [except for study supplied Gelusil (U.S. sites) or a similar equivalent approved antacid (ex U.S. sites)] throughout the study.
  • •4. Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
  • •5. Use of misoprostil or prokinetics throughout the study.
  • •6. Need for continuous anticoagulant therapy.
  • •7. Evidence of uncontrolled systemic disease.
  • •8. Subject who, in the opinion of the investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.

Investigators

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