Trial record 1 of 1 for:
T-GI04-088
Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn
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| ClinicalTrials.gov Identifier: NCT00255190 |
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Recruitment Status :
Completed
First Posted : November 17, 2005
Results First Posted : August 12, 2009
Last Update Posted : July 27, 2016
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Sponsor:
Takeda
Information provided by (Responsible Party):
Takeda
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastroesophageal Reflux Disease | Drug: Dexlansoprazole MR | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 591 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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) |
| Study Start Date : | January 2006 |
| Actual Primary Completion Date : | June 2008 |
| Actual Study Completion Date : | June 2008 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Dexlansoprazole MR 60 mg QD |
Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 12 months.
Other Names:
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| Experimental: Dexlansoprazole MR 90 mg QD |
Drug: Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 12 months.
Other Names:
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Primary Outcome Measures :
- Mean Change From Baseline to Month 12 for Hemoglobin Values [ Time Frame: Baseline and Month 12 ]
- Mean Change From Baseline to Month 12 for Hematocrit Values [ Time Frame: Baseline and Month 12 ]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 ]
- Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values [ Time Frame: Baseline and Month 12 ]
- Mean Change From Baseline to Month 12 for Platelet Count Values [ Time Frame: Baseline and Month 12 ]
- Mean Change From Baseline to Month 12 for White Blood Cell Count Values [ Time Frame: Baseline and Month 12 ]
- Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values [ Time Frame: Baseline and Month 12 ]
- Mean Change From Baseline to Month 12 for Creatinine Values [ Time Frame: Baseline and Month 12 ]
- Mean Change From Baseline to Month 12 for Calcium Values [ Time Frame: Baseline and Month 12 ]
- Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values [ Time Frame: Baseline and Month 12 ]
- Mean Change From Baseline to Month 12 for Total Bilirubin Values [ Time Frame: Baseline and Month 12 ]
- Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values [ Time Frame: Baseline and Month 12 ]
- Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values [ Time Frame: Baseline and Month 12 ]
- Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values [ Time Frame: Baseline and Month 12 ]
- Mean Change From Baseline to Month 12 for Serum Gastrin Levels [ Time Frame: Baseline and Month 12 ]
- Mean Change From Baseline to Month 12 for Systolic Blood Pressure [ Time Frame: Baseline and Month 12 ]
- Mean Change From Baseline to Month 12 for Diastolic Blood Pressure [ Time Frame: Baseline and Month 12 ]
- Mean Change From Baseline to Month 12 for Pulse Rate [ Time Frame: Baseline and Month 12 ]
- Changes From Baseline to Final Visit in Antrum Biopsy Results [ Time Frame: Baseline and Final Visit (up to 12 months) ]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) ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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).
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255190
Locations
Show 181 study locations
Sponsors and Collaborators
Takeda
Investigators
| Study Director: | Medical Director | Takeda |
Publications of Results:
| Responsible Party: | Takeda |
| ClinicalTrials.gov Identifier: | NCT00255190 |
| Other Study ID Numbers: |
T-GI04-088 U1111-1114-0151 ( Registry Identifier: WHO ) |
| First Posted: | November 17, 2005 Key Record Dates |
| Results First Posted: | August 12, 2009 |
| Last Update Posted: | July 27, 2016 |
| Last Verified: | April 2011 |
Keywords provided by Takeda:
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Gastroesophageal Reflux Disease |
Additional relevant MeSH terms:
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Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Dexlansoprazole |
Lansoprazole Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |