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Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00255190
First received: November 15, 2005
Last updated: April 25, 2011
Last verified: April 2011
  Purpose

The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.


Condition Intervention Phase
Gastroesophageal Reflux Disease
Drug: Dexlansoprazole MR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label Study to Assess the Long-Term Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD)

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Mean Change From Baseline to Month 12 for Hemoglobin Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Month 12 for Hematocrit Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
    Hematocrit measurement percent is the absolute difference in Hematocrit values, and not percentage difference.

  • Mean Change From Baseline to Month 12 for Red Blood Cell Count Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Month 12 for Platelet Count Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Month 12 for White Blood Cell Count Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Month 12 for Creatinine Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Month 12 for Calcium Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Month 12 for Total Bilirubin Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Month 12 for Serum Gastrin Levels [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Month 12 for Systolic Blood Pressure [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Month 12 for Diastolic Blood Pressure [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline to Month 12 for Pulse Rate [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
  • Changes From Baseline to Final Visit in Antrum Biopsy Results [ Time Frame: Baseline and Final Visit (up to 12 months) ] [ Designated as safety issue: Yes ]
    Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.

  • Changes From Baseline to Final Visit in Fundus Biopsy Results [ Time Frame: Baseline and Final Visit (up to 12 months) ] [ Designated as safety issue: Yes ]
    Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.


Secondary Outcome Measures:
  • Mean Change From Baseline to Month 1 for PAGI-QOL Total Score [ Time Frame: Baseline and Month 1 ] [ Designated as safety issue: No ]
    Mean overall composite Quality of Life (QOL) score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.

  • Mean Change From Baseline to Month 3 for PAGI-QOL Total Score [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.

  • Mean Change From Baseline to Month 6 for PAGI-QOL Total Score [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.

  • Mean Change From Baseline to Month 9 for PAGI-QOL Total Score [ Time Frame: Baseline and Month 9 ] [ Designated as safety issue: No ]
    Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.

  • Mean Change From Baseline to Month 12 for PAGI-QOL Total Score [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.

  • Mean Change From Baseline to Month 1 for PAGI-SYM Total Score [ Time Frame: Baseline and Month 1 ] [ Designated as safety issue: No ]
    Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).

  • Mean Change From Baseline to Month 3 for PAGI-SYM Total Score [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).

  • Mean Change From Baseline to Month 6 for PAGI-SYM Total Score [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).

  • Mean Change From Baseline to Month 9 for PAGI-SYM Total Score [ Time Frame: Baseline and Month 9 ] [ Designated as safety issue: No ]
    Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).

  • Mean Change From Baseline to Month 12 for PAGI-SYM Total Score [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).


Enrollment: 591
Study Start Date: January 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexlansoprazole MR 60 mg QD Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 12 months.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Experimental: Dexlansoprazole MR 90 mg QD Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 12 months.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant

Detailed Description:

This open-label study is intended to determine the long-term safety profile of dexlansoprazole MR over 12 months of dosing with 60 mg once-daily (QD) or 90 mg QD in subjects with gastroesophageal reflux disease (GERD), including those with esophageal erosions.

Prior to a protocol amendment, 300 subjects successfully completed one of the symptomatic nonerosive gastroesophageal reflux studies T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) in which they were randomly assigned to receive placebo or dexlansoprazole MR 60 or 90 mg QD. Subjects who were enrolled from one of these symptomatic GERD studies were randomly assigned in a 1:1 ratio to receive either dexlansoprazole MR 60 or 90 mg QD in this long-term study.

After implementation of protocol amendment #4, an additional 300 subjects with gastroesophageal reflux disease including those with erosive esophagitis will be enrolled and treated with dexlansoprazole MR 90 mg QD for 12 months.

Approximately 200 study sites in the U.S. will participate.

For all analyses involving visits during treatment from subjects enrolled prior to protocol amendment #4, baseline refers to pretreatment to Study T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758). For subjects enrolled under protocol amendment #4, baseline is based on screening or predosing measurement.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have successfully completed either T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) or have a diagnosis of gastroesophageal reflux disease with or without erosive esophagitis.

Exclusion Criteria:

  • Any condition that may require inpatient surgery during the course of the study.
  • Use of prescription or non-prescription proton pump inhibitors, histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study.
  • Use of antacids [except for study supplied Gelusil®].
  • Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study.
  • Evidence of uncontrolled systemic disease.
  • Allergy to any proton pump inhibitor including Prilosec, Nexium, Prevacid, or others, any component of dexlansoprazole MR, or Gelusil/antacid.
  • Need to take blood thinners.
  • Need to take more than 12 doses of non-steroidal anti-inflammatory drugs per month.
  • Had cancer (except basal cell cancer of the skin) within 3 years prior to screening.
  • Has other esophageal disease including Barrett's esophagus or strictures requiring dilation.
  • Has had radiation or cryotherapy to the esophagus.
  • Has active gastric or duodenal ulcers within 4 weeks of starting study drug.
  • Has a history of hypersecretory conditions such as Zollinger Ellison Syndrome.
  • History of alcohol abuse.
  • Has acquired immunodeficiency syndrome.
  • Has had acute upper gastrointestinal bleeding within 4 weeks of endoscopy.
  • Received a blood product transfusion within 3 months of taking the first dose of study drug.
  • Has previously participated in another dexlansoprazole MR long-term treatment clinical trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255190

  Show 181 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sr. VP Clinical Sciences, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00255190     History of Changes
Other Study ID Numbers: T-GI04-088, U1111-1113-9537
Study First Received: November 15, 2005
Results First Received: June 24, 2009
Last Updated: April 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Gastroesophageal Reflux Disease

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Dexlansoprazole
Lansoprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014