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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:
Information provided by (Responsible Party):
Takeda ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier:
NCT00762359
First received: September 26, 2008
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
Results First Received: February 3, 2011  
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
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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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  
Number of Participants  
[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 ]
  Show Outcome Measure 1

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

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

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

5.  Secondary:   Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)   [ Time Frame: Baseline and Month 12. ]
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6.  Secondary:   Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)   [ Time Frame: Baseline and Month 18. ]
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7.  Secondary:   Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)   [ Time Frame: Baseline and Month 3. ]
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8.  Secondary:   Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)   [ Time Frame: Baseline and Month 6. ]
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9.  Secondary:   Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)   [ Time Frame: Baseline and Month 9. ]
  Show Outcome Measure 9

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

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

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

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

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

15.  Secondary:   Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9)   [ Time Frame: Baseline and Month 9. ]
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16.  Secondary:   Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)   [ Time Frame: Baseline and Month 12. ]
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17.  Secondary:   Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)   [ Time Frame: Baseline and Month 18. ]
  Show Outcome Measure 17

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

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

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

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

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

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

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

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

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

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

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

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

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

Measure Type Secondary
Measure Title Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9)
Measure Description Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame Baseline and Month 9.  
Safety Issue No  

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.
Values are from the Full Analysis Set.

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.

Measured Values
    Lansoprazole 15 mg QD     Gefarnate 50 mg BID  
Number of Participants Analyzed  
[units: participants]
 		  111     86  
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9)  
[units: scores on a scale]
Mean ± Standard Deviation 		  -0.072  ± 0.260     0.012  ± 0.108  


Statistical Analysis 1 for Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9)
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] 0.0059
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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31.  Secondary:   Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)   [ Time Frame: Baseline and Month 12. ]
  Show Outcome Measure 31

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events
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  Other Adverse Events
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  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.


Limitations and Caveats
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.  


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


No publications provided


Responsible Party: Takeda ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier: NCT00762359     History of Changes
Other Study ID Numbers: AG-1749-CCT-351, 070494, U1111-1113-9929, R100125
Study First Received: September 26, 2008
Results First Received: February 3, 2011
Last Updated: February 1, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency