Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis

NCT00255164 | Completed Phase 3 Results

• 2 other identifiers: T-EE04-086U1111-1114-1355
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 96

Brief 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).

Conditions

Esophagitis, Reflux; Esophagitis, Peptic

Keywords

Erosive Esophagitis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (4)

• Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.

  6 months

• Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.

  6 months

• Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.

  6 months

• Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.

  6 months

Study Arms (3)

Dexlansoprazole MR 60 mg QD

EXPERIMENTAL

Drug: Dexlansoprazole MR

Dexlansoprazole MR 90 mg QD

EXPERIMENTAL

Drug: Dexlansoprazole MR

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dexlansoprazole MR DRUG

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

Also known as: TAK-390MR, Kapidex, Dexilant

Dexlansoprazole MR 60 mg QD

Placebo DRUG

Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or TEE04-085 (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (96)

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Alabaster, Alabama, United States

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Anaheim, California, United States

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Chula Vista, California, United States

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Fullerton, California, United States

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Garden Grove, California, United States

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Irvine, California, United States

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Lancaster, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Mission Hills, California, United States

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Palm Springs, California, United States

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Redwood City, California, United States

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San Diego, California, United States

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San Luis Obispo, California, United States

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Boulder, Colorado, United States

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Colorado Springs, Colorado, United States

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Lone Tree, Colorado, United States

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Wheat Ridge, Colorado, United States

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Waterbury, Connecticut, United States

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Boynton Beach, Florida, United States

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Jacksonville, Florida, United States

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Jupiter, Florida, United States

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Kissimmee, Florida, United States

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Lakeland, Florida, United States

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New Port Richey, Florida, United States

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Atlanta, Georgia, United States

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Honolulu, Hawaii, United States

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Arlington Heights, Illinois, United States

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Chicago, Illinois, United States

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Hines, Illinois, United States

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Oak Park, Illinois, United States

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Rockford, Illinois, United States

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Clive, Iowa, United States

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Dubuque, Iowa, United States

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Newton, Kansas, United States

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Shawnee Mission, Kansas, United States

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Topeka, Kansas, United States

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Metairie, Louisiana, United States

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Shreveport, Louisiana, United States

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Hollywood, Maryland, United States

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Lutherville, Maryland, United States

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Troy, Michigan, United States

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Chaska, Minnesota, United States

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Jackson, Mississippi, United States

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Mexico, Missouri, United States

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St Louis, Missouri, United States

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Washington, Missouri, United States

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Omaha, Nebraska, United States

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Pahrump, Nevada, United States

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New Brunswick, New Jersey, United States

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Bingampton, New York, United States

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Brooklyn, New York, United States

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Great Neck, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Elkin, North Carolina, United States

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Greensboro, North Carolina, United States

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Hickory, North Carolina, United States

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Salisbury, North Carolina, United States

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Statesville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Mayfield Heights, Ohio, United States

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Warren, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Beaver Falls, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Lansdale, Pennsylvania, United States

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Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Hermitage, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Beaumont, Texas, United States

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Bedford, Texas, United States

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Bryan, Texas, United States

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Corsicana, Texas, United States

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El Paso, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Bountiful, Utah, United States

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Ogden, Utah, United States

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Salt Lake City, Utah, United States

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West Jordan, Utah, United States

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Chesapeake, Virginia, United States

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Danville, Virginia, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Monroe, Wisconsin, United States

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Related Publications (3)

• 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: 10.1111/j.1365-2036.2009.04119.x. Epub 2009 Aug 14.

  PMID: 19681809 RESULT

• 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. doi: 10.1111/j.1365-2036.2009.04137.x. Epub 2009 Sep 4.

  PMID: 19735233 RESULT

• 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. Epub 2010 Feb 27.

  PMID: 20195905 RESULT

Related Links

• For the Dexilant package insert refer to this link

MeSH Terms

Conditions

Esophagitis, Peptic

Interventions

Dexlansoprazole; Lansoprazole

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Sr. VP Clinical Sciences
• Organization: Takeda Global Research and Development Center, Inc.

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2005
• First Posted: November 17, 2005
• Study Start: January 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: February 3, 2012
• Results First Posted: August 28, 2009

Record last verified: 2012-02

Locations

US (96)