We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 470 for:    aspirin AND prevention

Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin

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.
ClinicalTrials.gov Identifier: NCT01069939
Recruitment Status : Completed
First Posted : February 17, 2010
Results First Posted : November 22, 2012
Last Update Posted : November 22, 2012
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Prevention
Interventions: Drug: Esomeprazole
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First participant enrolled on 4 February 2010. On 20 May 2011, the efficacy analysis was completed based on positive results of an interim analysis so that the efficacy data in this report are at the interim analysis. To evaluate the safety, the study was continued. The last participant completed the study on 9 November 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 914 enrolled participants, 430 participants were assigned , but 484 participants were not assigned. The major reasons of no assignment were 'Did not meet eligibility criteria' (462 participants) and 'Voluntary discontinuation by participant' (21 participants). After 366 participants were randomised, the interim analysis was done.

Reporting Groups
  Description
Esomeprazole 20mg Esomeprazole 20mg once daily oral
Placebo Placebo once daily oral

Participant Flow for 2 periods

Period 1:   Randomised and Included in the Analyses
    Esomeprazole 20mg   Placebo
STARTED   213   214 
COMPLETED   164   137 
NOT COMPLETED   49   77 
Adverse Event                17                22 
Withdrawal by Subject                15                12 
Lost to Follow-up                1                1 
Protocol Violation                0                1 
Lack of Efficacy                0                1 
Study-specific withdrawal criteria                7                33 
Eligibility criteria not fulfilled                4                3 
Use of prohibited concomitant drug                4                2 
Physician Decision                0                2 
Removal                1                0 

Period 2:   At Data Cut Off Date (26 Feb 2011)
    Esomeprazole 20mg   Placebo
STARTED   213   214 
COMPLETED   182   182 
NOT COMPLETED   31   32 



  Baseline Characteristics

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
Esomeprazole 20mg Esomeprazole 20mg once daily oral
Placebo Placebo once daily oral
Total Total of all reporting groups

Baseline Measures
   Esomeprazole 20mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 213   214   427 
Age, Customized 
[Units: Participants]
     
<=64years   85   71   156 
Between 65 and 74 years   82   89   171 
>=75 years   46   54   100 
Gender 
[Units: Participants]
     
Female   43   46   89 
Male   170   168   338 
Region of Enrollment 
[Units: Participants]
     
Taiwan   22   21   43 
Japan   160   160   320 
Korea, Republic of   31   33   64 
Helicobacter pylori status [1] 
[Units: Participants]
     
Positive   93   93   186 
Negative   117   116   233 
[1] 8 participants had a missing for this measurement (3 participants in Esomeprazole 20 mg group and 5 participants in Placebo group). Negative means a patient had no Helicobacter pylori infection and Positive means a patient had Helicobacter pylori infection.


  Outcome Measures

1.  Primary:   Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis.   [ Time Frame: From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis) ]

2.  Secondary:   Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48   [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]

3.  Secondary:   Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48.   [ Time Frame: 12, 24, 36 and 48 weeks ]

4.  Secondary:   Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48   [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]

5.  Secondary:   Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48.   [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]

6.  Secondary:   Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48   [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]

7.  Secondary:   Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week   [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]

8.  Secondary:   Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48   [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]

9.  Secondary:   Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48   [ Time Frame: Up to 48 weeks (Baseline to last measurement) ]

10.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: Up to 70 weeks at the longest ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01069939     History of Changes
Other Study ID Numbers: D961PC00001
First Submitted: February 16, 2010
First Posted: February 17, 2010
Results First Submitted: October 24, 2012
Results First Posted: November 22, 2012
Last Update Posted: November 22, 2012