Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis

This study has been completed.

Study NCT00251719 Information provided by Takeda Global Research & Development Center, Inc.

First Received on November 8, 2005. Last Updated on February 1, 2012 History of Changes

Results First Received: February 20, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Esophagitis, Reflux Esophagitis, Peptic
Interventions:	Drug: Dexlansoprazole MR Drug: Lansoprazole

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at 93 sites in the US and 63 ex-US sites from 16 December 2005 to 22 January 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects recorded day and nighttime heartburn symptoms and rescue medications for a screening period of up to 21 days. Subjects with endoscopically-proven erosive esophagitis (EE) at screening were enrolled in Dexlansoprazole Modified Release (MR) or Lansoprazole once daily (QD) treatment group.

Reporting Groups

	Description
Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
Dexlansoprazole MR 90 mg QD	Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
Lansoprazole 30 mg QD	Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Participant Flow: Overall Study

	Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR 90 mg QD	Lansoprazole 30 mg QD
STARTED	694	687	673
COMPLETED	641	642	643
NOT COMPLETED	53	45	30
Adverse Event	14	8	7
Protocol Violation	1	1	1
Lost to Follow-up	5	11	8
Withdrawal by Subject	14	12	11
Lack of Efficacy	2	1	0
Inclusion/exclusion criteria not met	12	6	2
Investigator decision	1	1	0
Noncompliance	2	3	1
Barrett's esophagus	2	2	0

Baseline Characteristics

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Reporting Groups

	Description
Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
Dexlansoprazole MR 90 mg QD	Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
Lansoprazole 30 mg QD	Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Baseline Measures

	Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR 90 mg QD	Lansoprazole 30 mg QD	Total
Number of Participants [units: participants]	694	687	673	2054
Age, Customized [units: participants]
< 45 Years	255	293	294	842
45 Years to < 65 Years	348	310	314	972
>= 65 Years	91	84	65	240
Age [units: years] Mean ± Standard Deviation	48.7 ± 13.53	47.7 ± 13.80	47.3 ± 13.65	47.9 ± 13.66
Gender [units: participants]
Female	317	335	311	963
Male	377	352	362	1091
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	67	67	58	192
Not Hispanic or Latino	627	620	615	1862
Unknown or Not Reported	0	0	0	0
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	6	12	7	25
Asian	33	32	25	90
Native Hawaiian or Other Pacific Islander	1	1	0	2
Black or African American	34	30	32	96
White	598	588	584	1770
More than one race	21	23	24	68
Unknown or Not Reported	1	1	1	3
LA Classification Grade [units: participant]
A: ≥1 mucosal break <5 mm	234	271	222	727
B: ≥1 mucosal break ≥5 mm	257	221	257	735
C: ≥1 mucosal break and <75% of the circumference	156	152	150	458
D: ≥1 mucosal break and ≥75% of the circumference	46	42	44	132
NA	1	1	0	2

Outcome Measures

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1. Primary:

Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis. [ Time Frame: 8 Weeks ]

Show Outcome Measure 1

2. Primary:

Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method [ Time Frame: 8 Weeks ]

Show Outcome Measure 2

3. Secondary:

Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis. [ Time Frame: Week 8 ]

Show Outcome Measure 3

4. Secondary:

Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method. [ Time Frame: 8 Weeks ]

Show Outcome Measure 4

5. Secondary:

Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analysis. [ Time Frame: 4 Weeks ]

Show Outcome Measure 5

6. Secondary:

Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method [ Time Frame: 4 Weeks ]

Show Outcome Measure 6

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Sr. VP Clinical Sciences
Organization: Takeda Global Research & Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com

Publications of Results:

Sharma P, Shaheen NJ, Perez MC, Pilmer BL, Lee M, Atkinson SN, Peura D. Clinical trials: healing of erosive oesophagitis with dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed-release formulation--results from two randomized controlled studies. Aliment Pharmacol Ther. 2009 Apr 1;29(7):731-41.

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. Epub 2009 Sep 4.

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. Epub 2010 Feb 27.

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. Epub 2010 Nov 24.

Responsible Party:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00251719 History of Changes
Other Study ID Numbers:	T-EE04-085, U1111-1114-0058
Study First Received:	November 8, 2005
Results First Received:	February 20, 2009
Last Updated:	February 1, 2012
Health Authority:	United States: Food and Drug Administration