Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00787254
First received: November 6, 2008
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to determine whether AG-1749 (lansoprazole), once daily (QD), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with nonsteroid anti-inflammatory drug, compared to gefarnate, twice daily (BID).


Condition Intervention Phase
Stomach Ulcer
Duodenal Ulcer
Drug: Lansoprazole
Drug: Gefarnate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Investigate the Preventive Effect of AG-1749 Against the Recurrence of Gastric and Duodenal Ulcers During Long-term Treatment With Nonsteroid Anti-inflammatory Drug

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Number of Participants With Gastric Ulcer and/or Duodenal Ulcer [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    The number of participants that developed gastric ulcer and/or duodenal ulcer at month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.


Secondary Outcome Measures:
  • Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) [ Time Frame: Baseline and Month 3. ] [ Designated as safety issue: No ]
    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.

  • Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) [ Time Frame: Baseline and Month 6. ] [ Designated as safety issue: No ]
    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.

  • Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) [ Time Frame: Baseline and Month 12. ] [ Designated as safety issue: No ]
    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.

  • Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18) [ Time Frame: Baseline and Month 18. ] [ Designated as safety issue: No ]
    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.

  • Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24) [ Time Frame: Baseline and Month 24. ] [ Designated as safety issue: No ]
    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.

  • Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) [ Time Frame: Baseline and Month 3. ] [ Designated as safety issue: No ]
    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.

  • Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) [ Time Frame: Baseline and Month 6. ] [ Designated as safety issue: No ]
    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.

  • Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) [ Time Frame: Baseline and Month 12. ] [ Designated as safety issue: No ]
    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.

  • Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18) [ Time Frame: Baseline and Month 18. ] [ Designated as safety issue: No ]
    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.

  • Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24) [ Time Frame: Baseline and Month 24. ] [ Designated as safety issue: No ]
    The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.

  • Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage) [ Time Frame: On occurrence (up to month 24). ] [ Designated as safety issue: No ]
    Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.

  • Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3) [ Time Frame: Baseline and Month 3. ] [ Designated as safety issue: No ]
    The number of participants that develop postprandial pain at month 3, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6) [ Time Frame: Baseline and Month 6. ] [ Designated as safety issue: No ]
    The number of participants that develop postprandial pain at month 6, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12) [ Time Frame: Baseline and Month 12. ] [ Designated as safety issue: No ]
    The number of participants that develop postprandial pain at month 12, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18) [ Time Frame: Baseline and Month 18. ] [ Designated as safety issue: No ]
    The number of participants that develop postprandial pain at month 18, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24) [ Time Frame: Baseline and Month 24. ] [ Designated as safety issue: No ]
    The number of participants that develop postprandial pain at month 24, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3) [ Time Frame: Baseline and Month 3. ] [ Designated as safety issue: No ]
    The number of participants that develop hunger and nighttime pain at month 3, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6) [ Time Frame: Baseline and Month 6. ] [ Designated as safety issue: No ]
    The number of participants that develop hunger and nighttime pain at month 6, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12) [ Time Frame: Baseline and Month 12. ] [ Designated as safety issue: No ]
    The number of participants that develop hunger and nighttime pain at month 12, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18) [ Time Frame: Baseline and Month 18. ] [ Designated as safety issue: No ]
    The number of participants that develop hunger and nighttime pain at month 18, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24) [ Time Frame: Baseline and Month 24. ] [ Designated as safety issue: No ]
    The number of participants that develop hunger and nighttime pain at month 24, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3) [ Time Frame: Baseline and Month 3. ] [ Designated as safety issue: No ]
    The number of participants that develop the feeling of an enlarged abdomen at month 3, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6) [ Time Frame: Baseline and Month 6. ] [ Designated as safety issue: No ]
    The number of participants that develop the feeling of an enlarged abdomen at month 6, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12) [ Time Frame: Baseline and Month 12. ] [ Designated as safety issue: No ]
    The number of participants that develop the feeling of an enlarged abdomen at month 12, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18) [ Time Frame: Baseline and Month 18. ] [ Designated as safety issue: No ]
    The number of participants that develop the feeling of an enlarged abdomen at month 18, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24) [ Time Frame: Baseline and Month 24. ] [ Designated as safety issue: No ]
    The number of participants that develop the feeling of an enlarged abdomen at month 24, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3) [ Time Frame: Baseline and Month 3. ] [ Designated as safety issue: No ]
    The number of participants that develop the feeling of nausea at month 3, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6) [ Time Frame: Baseline and Month 6. ] [ Designated as safety issue: No ]
    The number of participants that develop the feeling of nausea at month 6, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12) [ Time Frame: Baseline and Month 12. ] [ Designated as safety issue: No ]
    The number of participants that develop the feeling of nausea at month 12, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18) [ Time Frame: Baseline and Month 18. ] [ Designated as safety issue: No ]
    The number of participants that develop the feeling of nausea at month 18, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24) [ Time Frame: Baseline and Month 24. ] [ Designated as safety issue: No ]
    The number of participants that develop the feeling of nausea at month 24, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3) [ Time Frame: Baseline and Month 3. ] [ Designated as safety issue: No ]
    The number of participants that develop the feeling of heartburn at month 3, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6) [ Time Frame: Baseline and Month 6. ] [ Designated as safety issue: No ]
    The number of participants that develop the feeling of heartburn at month 6, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12) [ Time Frame: Baseline and Month 12. ] [ Designated as safety issue: No ]
    The number of participants that develop the feeling of heartburn at month 12, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18) [ Time Frame: Baseline and Month 18. ] [ Designated as safety issue: No ]
    The number of participants that develop the feeling of heartburn at month 18, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24) [ Time Frame: Baseline and Month 24. ] [ Designated as safety issue: No ]
    The number of participants that develop the feeling of heartburn at month 24, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3) [ Time Frame: Baseline and Month 3. ] [ Designated as safety issue: No ]
    The number of participants that develop anorexia at month 3, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6) [ Time Frame: Baseline and Month 6. ] [ Designated as safety issue: No ]
    The number of participants that develop anorexia at month 6, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12) [ Time Frame: Baseline and Month 12. ] [ Designated as safety issue: No ]
    The number of participants that develop anorexia at month 12, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18) [ Time Frame: Baseline and Month 18. ] [ Designated as safety issue: No ]
    The number of participants that develop anorexia at month 18, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 24) [ Time Frame: Baseline and Month 24. ] [ Designated as safety issue: No ]
    The number of participants that develop anorexia at month 24, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3) [ Time Frame: Baseline and Month 3. ] [ Designated as safety issue: No ]
    The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 3, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6) [ Time Frame: Baseline and Month 6. ] [ Designated as safety issue: No ]
    The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 6, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12) [ Time Frame: Baseline and Month 12. ] [ Designated as safety issue: No ]
    The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 12, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18) [ Time Frame: Baseline and Month 18. ] [ Designated as safety issue: No ]
    The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 18, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24) [ Time Frame: Baseline and Month 24. ] [ Designated as safety issue: No ]
    The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 24, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.

  • Number of Participants With Adverse Events [ Time Frame: Per Incidence (up to 24 months). ] [ Designated as safety issue: Yes ]
    Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.


Enrollment: 366
Study Start Date: April 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lansoprazole 15 mg QD Drug: Lansoprazole
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Other Name: AG-1749
Active Comparator: Gefarnate 50 mg BID Drug: Gefarnate
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.

Detailed Description:

In Japan, nonsteroid anti-inflammatory drug is one of common prescribed drugs for patients as an analgesic antipyretic, treating symptoms of cold, antiphlogistic and management of pain with rheumatoid arthritis, osteoarthrosis, lumbago. On the other hand, this nonsteroid anti-inflammatory drug sometimes causes gastric and duodenal ulcers and this ulcer leads to the gastrointestinal bleeding which may be cause of death.

The purpose of this study is to assess the efficacy of lansoprazole versus gefarnate in patients with a history of gastric or duodenal ulcers receiving daily nonsteroid anti-inflammatory medication.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient was on nonsteroid anti-inflammatory drug (NSAID) treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started.
  • The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.

Exclusion Criteria:

  • Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.
  • Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.
  • Current or past history of aspirin-induced asthma or hypersensitivity to NSAIDs.
  • Past or planned surgery affecting gastric acid secretion.
  • Clinically significant hepatic or renal disorder.
  • Serious cardiac dysfunction, hypertension, or hematological disorder.
  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: NCT00787254

  Show 68 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: General Manager Takeda
  More Information

Additional Information:
No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00787254     History of Changes
Other Study ID Numbers: AG-1749-CCT-352, 070495, U1111-1114-2071, R100126
Study First Received: November 6, 2008
Results First Received: February 3, 2011
Last Updated: February 1, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Takeda:
Curling Ulcer
Gastric Ulcer
Nonsteroid anti-inflammatory drug
Drug Therapy

Additional relevant MeSH terms:
Duodenal Ulcer
Stomach Ulcer
Ulcer
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Gefarnate
Lansoprazole
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014