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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00255151
Other study ID # T-EE04-087
Secondary ID U1111-1114-1767
Status Completed
Phase Phase 3
First received November 15, 2005
Last updated February 1, 2012
Start date January 2006
Est. completion date November 2006

Study information

Verified date February 2012
Source Takeda
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).


Description:

This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo, in maintaining healing of erosive esophagitis.

Because the development plan for Dexlansoprazole MR formulation was revised, the results of 2 identical studies, T-EE04-086 (NCT00255164) and T-EE04-087 (this study, NCT00255151), were combined and analyzed as a single larger study referred to as study T-EE04-086. A total of 451 subjects were included in the combined analysis: 237 subjects were enrolled into Study T-EE04-086, and 214 subjects were enrolled into Study T-EE04-087.


Recruitment information / eligibility

Status Completed
Enrollment 451
Est. completion date November 2006
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or T-EE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy. Complete healing was assessed for change in LA Esophagitis Classification grades A, B, C, or D to healed (defined as anything less than the criterion for Grade A). The subject was counted as healed if endoscopy findings did not meet the Grade A criterion.

Exclusion Criteria:

- Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study

- Use of antacids (except for study supplied) throughout the study.

- Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.

- Need for continuous anticoagulant therapy.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.
Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.
Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Takeda

Country where clinical trial is conducted

United States, 

References & Publications (1)

Howden CW, Larsen LM, Perez MC, Palmer R, Atkinson SN. Clinical trial: efficacy and safety of dexlansoprazole MR 60 and 90 mg in healed erosive oesophagitis - maintenance of healing and symptom relief. Aliment Pharmacol Ther. 2009 Nov 1;30(9):895-907. doi — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis. Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed. 6 months No
Primary Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored. 6 months No
Secondary Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median. The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported. 6 months No
Secondary Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean. The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked 6 months No
Secondary Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median. The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked. 6 months No
Secondary Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean. The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked. 6 months No
See also
  Status Clinical Trial Phase
Completed NCT02463643 - To Evaluate Efficacy and Safety of Z-215 in Erosive Esophagitis Phase 2
Completed NCT00321737 - Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis Phase 3
Completed NCT00255164 - Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis Phase 3
Suspended NCT00282555 - Efficiency Study of S-Tenatoprazole-Na to Treat Erosive or Ulcerative Esophagitis Phase 2
Completed NCT00251719 - Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis Phase 3
Completed NCT00251693 - Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis Phase 3
Not yet recruiting NCT05418920 - Clinical Trial of Reconstruction After Proximal Gastrectomy N/A
Recruiting NCT02049723 - Assessment of GERD Knowledge Level Among Patients With it in Korea N/A