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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00321737
Other study ID # T-EE05-135
Secondary ID 2006-000419-90U1
Status Completed
Phase Phase 3
First received May 2, 2006
Last updated February 1, 2012
Start date May 2006
Est. completion date May 2007

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) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).


Description:

This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily dexlansoprazole MR (30 mg and 60 mg) with that of placebo, in maintaining healing of EE.


Recruitment information / eligibility

Status Completed
Enrollment 445
Est. completion date May 2007
Est. primary completion date May 2007
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.

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

- Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.

- Need for continuous anticoagulant therapy.

- Evidence of uncontrolled systemic disease.

- Subjects who have participated in either maintenance study (T-EE04-086 [NCT00255164] or T-EE04-087 [NCT00255151]).

- Subjects who, in the opinion of the investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.

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 30 mg, capsules, orally, once daily for up to six months.
Dexlansoprazole MR
Dexlansoprazole MR 60 mg, 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

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czech Republic,  Estonia,  Latvia,  Lithuania,  Slovakia, 

References & Publications (4)

Friedlander EA, Pallentino J, Miller SK, VanBeuge SS. The evolution of proton pump inhibitors for the treatment of gastroesophageal reflux disease. J Am Acad Nurse Pract. 2010 Dec;22(12):674-83. doi: 10.1111/j.1745-7599.2010.00578.x. Epub 2010 Nov 24. Rev — View Citation

Metz DC, Howden CW, Perez MC, Larsen L, O'Neil J, Atkinson SN. Clinical trial: dexlansoprazole MR, a proton pump inhibitor with dual delayed-release technology, effectively controls symptoms and prevents relapse in patients with healed erosive oesophagiti — View Citation

Peura DA, Metz DC, Dabholkar AH, Paris MM, Yu P, Atkinson SN. Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1010-21 — View Citation

Wyrwich KW, Mody R, Larsen LM, Lee M, Harnam N, Revicki DA. Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants. Qual Life Res. 2010 May;19(4):551-64. doi: 10.1007/s11136-010-9620-x. Epu — 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 NCT00255151 - Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain 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