Safety and Efficacy of Lansoprazole in Patients With Reflux Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01135368
First received: June 1, 2010
Last updated: July 25, 2012
Last verified: July 2012
Results First Received: July 25, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastroesophageal Reflux
Intervention: Drug: Lansoprazole

  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 took part in the study at 38 investigative sites in Germany from 18 June 2002 to 24 September 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a historical diagnosis of Gastro Esophageal Reflux disease (GERD) received treatment with Lansoprazole at the usual dosage.

Reporting Groups
  Description
Lansoprazole

Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months.


Participant Flow:   Overall Study
    Lansoprazole  
STARTED     506  
COMPLETED     255  
NOT COMPLETED     251  



  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

Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months.


Baseline Measures
    Lansoprazole  
Number of Participants  
[units: participants]
  506  
Age  
[units: years]
Mean ± Standard Deviation
  53.5  ± 12.1  
Gender  
[units: participants]
 
Female     218  
Male     288  
Race/Ethnicity, Customized  
[units: participants]
 
Caucasian     502  
Black     2  
Oriental     2  
Height  
[units: cm]
Mean ± Standard Deviation
  171.1  ± 9.3  
Weight  
[units: kg]
Mean ± Standard Deviation
  82.2  ± 13.7  
Body Mass Index (BMI)  
[units: kg/cm^2]
Mean ± Standard Deviation
  28.09  ± 4.15  
Diagnosis of Reflux Disease  
[units: participants]
 
First diagnosis     150  
Recurrence     356  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Reflux Disease Symptom - Heartburn   [ Time Frame: Baseline and Week 8 ]

2.  Primary:   Change From Baseline in Reflux Disease Symptoms - Acid Regurgitation   [ Time Frame: Baseline and Week 8 ]

3.  Primary:   Change From Baseline in Reflux Disease Symptom - Difficulty Swallowing   [ Time Frame: Baseline and Week 8 ]

4.  Primary:   Change From Baseline in Reflux Disease Symptom - Pain in Upper Abdomen   [ Time Frame: Baseline and Week 8 ]

5.  Primary:   Change From Baseline in Reflux Disease Symptom - Nausea & Vomiting   [ Time Frame: Baseline and Week 8 ]

6.  Primary:   Change From Baseline in Reflux Disease Symptom - Cough & Sore Throat   [ Time Frame: Baseline and Week 8 ]

7.  Primary:   Change From Baseline in Endoscopic Healing of Erosive Reflux Disease as Assessed by Endoscopy   [ Time Frame: Baseline and Week 8 ]

8.  Secondary:   Change From Baseline in Enterochromaffin-like Cell Hyperplasia   [ Time Frame: Baseline and Year 5 ]

9.  Secondary:   Change From Baseline in Antrum Atrophy   [ Time Frame: Baseline and Year 5 ]

10.  Secondary:   Change From Baseline in Corpus Atrophy   [ Time Frame: Baseline and Year 5 ]

11.  Secondary:   Change From Baseline in Average Antrum Chronic Inflammation Score   [ Time Frame: Baseline and Year 5 ]

12.  Secondary:   Change From Baseline in Corpus Chronic Inflammation Score   [ Time Frame: Baseline and Year 5 ]

13.  Secondary:   Change From Baseline in Antrum Intestinal Metaplasia   [ Time Frame: Baseline and Year 5 ]

14.  Secondary:   Change From Baseline in Corpus Intestinal Metaplasia   [ Time Frame: Baseline and Year 5 ]

15.  Secondary:   Change From Baseline in Blood Analysis - Testosterone   [ Time Frame: Baseline and Year 5 ]

16.  Secondary:   Change From Baseline in Blood Analysis - Luteinizing Hormone   [ Time Frame: Baseline and Year 5 ]

17.  Secondary:   Change From Baseline in Blood Analysis - Follicle Stimulating Hormone   [ Time Frame: Baseline and Year 5. ]

18.  Secondary:   Ophthalmologic Examination - Visual Acuity   [ Time Frame: Baseline and Year 5 ]

19.  Secondary:   Change From Baseline in Ophthalmologic Examination - Adaptation Without Glare   [ Time Frame: Baseline and Year 5 ]

20.  Secondary:   Change From Baseline in Ophthalmologic Examination - Adaptation With Glare   [ Time Frame: Baseline and Year 5 ]

21.  Secondary:   Change From Baseline in Ophthalmologic Examination - Accommodation   [ Time Frame: Baseline and Year 5 ]

22.  Secondary:   Change From Baseline in Ophthalmologic Examination - Color Vision   [ Time Frame: Baseline and Year 5 ]

23.  Secondary:   Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Right Eye   [ Time Frame: Baseline and Year 5 ]

24.  Secondary:   Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Left Eye   [ Time Frame: Baseline and Year 5 ]

25.  Secondary:   Change From Baseline in Ophthalmologic Examination - Lens Assessment of Right Eye   [ Time Frame: Baseline and Year 5 ]

26.  Secondary:   Change From Baseline in Ophthalmologic Examination - Lens Assessment of Left Eye   [ Time Frame: Baseline and Year 5 ]

27.  Secondary:   Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Right Eye   [ Time Frame: Baseline and Year 5 ]

28.  Secondary:   Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Left Eye   [ Time Frame: Baseline and Year 5 ]

29.  Secondary:   Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Right Eye   [ Time Frame: Baseline and Year 5 ]

30.  Secondary:   Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Left Eye   [ Time Frame: Baseline and Year 5 ]

31.  Secondary:   Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Right Eye   [ Time Frame: Baseline and Year 5 ]

32.  Secondary:   Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Left Eye   [ Time Frame: Baseline and Year 5 ]

33.  Secondary:   Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Right Eye   [ Time Frame: Baseline and Year 5 ]

34.  Secondary:   Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Left Eye   [ Time Frame: Baseline and Year 5 ]

35.  Secondary:   Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Right Eye   [ Time Frame: Baseline and Year 5 ]

36.  Secondary:   Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Left Eye   [ Time Frame: Baseline and Year 5 ]


  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
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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.


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
ClinicalTrials.gov Identifier: NCT01135368     History of Changes
Other Study ID Numbers: AGO K019, U1111-1115-1139
Study First Received: June 1, 2010
Results First Received: July 25, 2012
Last Updated: July 25, 2012
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration