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 Global Research & Development Center, Inc. ( 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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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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. ]

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11. Secondary:

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

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12. Secondary:

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

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13. Secondary:

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

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14. Secondary:

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

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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. ]

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18. Secondary:

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

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19. Secondary:

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

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20. Secondary:

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

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21. Secondary:

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

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22. Secondary:

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

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23. Secondary:

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

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24. Secondary:

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

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25. Secondary:

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

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26. Secondary:

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

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27. Secondary:

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

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28. Secondary:

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

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29. Secondary:

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

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30. Secondary:

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

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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. ]

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32. Secondary:

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

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33. Secondary:

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

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34. Secondary:

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

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35. Secondary:

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

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36. Secondary:

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

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37. Secondary:

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

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38. Secondary:

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

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39. Secondary:

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

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Measure Type	Secondary
Measure Title	Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)
Measure Description	Severity of anorexia 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 6.
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]	158	133
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6) [units: scores on a scale] Mean ± Standard Deviation	-0.019 ± 0.177	0.000 ± 0.246

Statistical Analysis 1 for Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)

Groups ^[1]	All groups
Method ^[2]	Wilcoxon (Mann-Whitney)
P Value ^[3]	0.4496

[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:
	No text entered.

40. Secondary:

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

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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. ]

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43. Secondary:

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

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44. Secondary:

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

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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 ]

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The clinical trial contract states that information should never be disclosed without prior consent of the sponsor, although it does not specify the number of days during which disclosure of information is limited.

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 Global Research & Development Center, Inc. ( 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

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