Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis

NCT00255151 | Completed Phase 3 Results

• 2 other identifiers: T-EE04-087U1111-1114-1767
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 100

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, Dexilant, Kapidex

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 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.

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 (100)

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Anniston, Alabama, United States

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Hueytown, Alabama, United States

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Huntsville, Alabama, United States

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Tallassee, Alabama, United States

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Tuscaloosa, Alabama, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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North Little Rock, Arkansas, United States

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Azusa, California, United States

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Carmichael, California, United States

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Cypress, California, United States

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Fresno, California, United States

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Los Angeles, California, United States

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Modesto, California, United States

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Newport Beach, California, United States

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Oakland, California, United States

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Orange, California, United States

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San Diego, California, United States

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Santa Maria, California, United States

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Littleton, Colorado, United States

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Longmont, Colorado, United States

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Wheat Ridge, Colorado, United States

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Bristol, Connecticut, United States

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Newark, Delaware, United States

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Fort Myers, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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New Smyrna Beach, Florida, United States

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Ocala, Florida, United States

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Pembroke Pines, Florida, United States

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Port Orange, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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Zephyrhills, Florida, United States

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Atlanta, Georgia, United States

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Champaign, Illinois, United States

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Moline, Illinois, United States

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North Chicago, Illinois, United States

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Oak Forest, Illinois, United States

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Springfield, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Newburgh, Indiana, United States

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Davenport, Iowa, United States

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Kansas City, Kansas, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Chevy Chase, Maryland, United States

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Prince Frederick, Maryland, United States

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Jackson, Mississippi, United States

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Jefferson City, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Missoula, Montana, United States

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Egg Harbor, New Jersey, United States

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Albuquerque, New Mexico, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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High Point, North Carolina, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Akron, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Mogadore, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Anderson, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Chattanooga, Tennessee, United States

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Germantown, Tennessee, United States

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Jackson, Tennessee, United States

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Johnson City, Tennessee, United States

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Kingsport, Tennessee, United States

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Amarillo, Texas, United States

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Conroe, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Odessa, Texas, United States

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Pharr, Texas, United States

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Seguin, Texas, United States

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Temple, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Bellevue, Washington, United States

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Lakewood, Washington, United States

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Tacoma, Washington, United States

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Milwaukee, Wisconsin, United States

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

  PMID: 19681809 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 CHAIR

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 (100)