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A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers

This study has been terminated.
(AG-1749 superior to Gefarnate in ulcer prevention)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00762359
First Posted: September 30, 2008
Last Update Posted: February 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
Results First Submitted: February 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Stomach Ulcer
Duodenal Ulcer
Interventions: Drug: Lansoprazole
Drug: Gefarnate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at sites in Japan from May 2007 to November 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were enrolled in either lansoprazole, once daily (QD) or gefarnate, twice daily (BID) treatment groups.

Reporting Groups
  Description
Lansoprazole 15 mg QD Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
Gefarnate 50 mg BID Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.

Participant Flow:   Overall Study
    Lansoprazole 15 mg QD   Gefarnate 50 mg BID
STARTED   226   235 
COMPLETED   167   178 
NOT COMPLETED   59   57 
Adverse Event                20                23 
Protocol Violation                21                13 
Withdrawal by Subject                13                10 
Lack of Efficacy                0                4 
Institution closed                2                3 
Physician Decision                2                3 
Removal                0                1 
Withdrew consent                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lansoprazole 15 mg QD Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
Gefarnate 50 mg BID Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Total Total of all reporting groups

Baseline Measures
   Lansoprazole 15 mg QD   Gefarnate 50 mg BID   Total 
Overall Participants Analyzed 
[Units: Participants]
 226   235   461 
Age, Customized 
[Units: Participants]
     
<=39 years   1   0   1 
Between 40 and 49 years   1   4   5 
Between 50 and 59 years   31   36   67 
Between 60 and 64 years   28   32   60 
Between 65 and 69 years   38   53   91 
Between 70 and 79 years   105   81   186 
<=80 years   22   29   51 
Gender 
[Units: Participants]
     
Female   51   43   94 
Male   175   192   367 
Region of Enrollment 
[Units: Participants]
     
Japan   226   235   461 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Gastric Ulcer and/or Duodenal Ulcer   [ Time Frame: 18 Months ]

2.  Secondary:   Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)   [ Time Frame: Baseline and Month 3. ]

3.  Secondary:   Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)   [ Time Frame: Baseline and Month 6. ]

4.  Secondary:   Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)   [ Time Frame: Baseline and Month 9. ]

5.  Secondary:   Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)   [ Time Frame: Baseline and Month 12. ]

6.  Secondary:   Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)   [ Time Frame: Baseline and Month 18. ]

7.  Secondary:   Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)   [ Time Frame: Baseline and Month 3. ]

8.  Secondary:   Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)   [ Time Frame: Baseline and Month 6. ]

9.  Secondary:   Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)   [ Time Frame: Baseline and Month 9. ]

10.  Secondary:   Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)   [ Time Frame: Baseline and Month 12. ]

11.  Secondary:   Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)   [ Time Frame: Baseline and Month 18. ]

12.  Secondary:   Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)   [ Time Frame: 18 Months ]

13.  Secondary:   Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)   [ Time Frame: Baseline and Month 3. ]

14.  Secondary:   Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)   [ Time Frame: Baseline and Month 6. ]

15.  Secondary:   Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9)   [ Time Frame: Baseline and Month 9. ]

16.  Secondary:   Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)   [ Time Frame: Baseline and Month 12. ]

17.  Secondary:   Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)   [ Time Frame: Baseline and Month 18. ]

18.  Secondary:   Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)   [ Time Frame: Baseline and Month 3. ]

19.  Secondary:   Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)   [ Time Frame: Baseline and Month 6. ]

20.  Secondary:   Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9)   [ Time Frame: Baseline and Month 9. ]

21.  Secondary:   Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)   [ Time Frame: Baseline and Month 12. ]

22.  Secondary:   Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)   [ Time Frame: Baseline and Month 18. ]

23.  Secondary:   Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)   [ Time Frame: Baseline and Month 3. ]

24.  Secondary:   Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)   [ Time Frame: Baseline and Month 6. ]

25.  Secondary:   Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9)   [ Time Frame: Baseline and Month 9. ]

26.  Secondary:   Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)   [ Time Frame: Baseline and Month 12. ]

27.  Secondary:   Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)   [ Time Frame: Baseline and Month 18. ]

28.  Secondary:   Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)   [ Time Frame: Baseline and Month 3. ]

29.  Secondary:   Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)   [ Time Frame: Baseline and Month 6. ]

30.  Secondary:   Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9)   [ Time Frame: Baseline and Month 9. ]

31.  Secondary:   Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)   [ Time Frame: Baseline and Month 12. ]

32.  Secondary:   Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)   [ Time Frame: Baseline and Month 18. ]

33.  Secondary:   Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)   [ Time Frame: Baseline and Month 3. ]

34.  Secondary:   Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)   [ Time Frame: Baseline and Month 6. ]

35.  Secondary:   Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9)   [ Time Frame: Baseline and Month 9. ]

36.  Secondary:   Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)   [ Time Frame: Baseline and Month 12. ]

37.  Secondary:   Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)   [ Time Frame: Baseline and Month 18. ]

38.  Secondary:   Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)   [ Time Frame: Baseline and Month 3. ]

39.  Secondary:   Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)   [ Time Frame: Baseline and Month 6. ]

40.  Secondary:   Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9)   [ Time Frame: Baseline and Month 9. ]

41.  Secondary:   Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)   [ Time Frame: Baseline and Month 12. ]

42.  Secondary:   Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)   [ Time Frame: Baseline and Month 18. ]

43.  Secondary:   Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)   [ Time Frame: Baseline and Month 3. ]

44.  Secondary:   Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)   [ Time Frame: Baseline and Month 6. ]

45.  Secondary:   Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9)   [ Time Frame: Baseline and Month 9. ]

46.  Secondary:   Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)   [ Time Frame: Baseline and Month 12. ]

47.  Secondary:   Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)   [ Time Frame: Baseline and Month 18. ]

48.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 18 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
On September 2008, the Efficacy and Safety Evaluation Committee recommended that this study be discontinued based on the interim analysis.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sr. VP Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00762359     History of Changes
Other Study ID Numbers: AG-1749-CCT-351
070494 ( Registry Identifier: JapicCTI )
U1111-1113-9929 ( Registry Identifier: WHO )
R100125 ( Registry Identifier: JapicCTI )
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: February 3, 2011
Results First Posted: May 10, 2011
Last Update Posted: February 3, 2012



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