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Trial record 1 of 3 for:    "Barrett Esophagus" | "Lansoprazole"
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Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation

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ClinicalTrials.gov Identifier: NCT02162758
Recruitment Status : Terminated (Business Decisions; No Safety Concerns)
First Posted : June 13, 2014
Results First Posted : May 11, 2017
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Barrett's Esophagus
Interventions Drug: Dexlansoprazole
Drug: Dexlansoprazole Placebo
Enrollment 6
Recruitment Details Participants took part in the study at 2 investigative sites in the United States from 16 July 2014 to 09 May 2016.
Pre-assignment Details Participants with a diagnosis of Barrett’s esophagus (BE) who had achieved complete eradication of intestinal metaplasia (CEIM) with radiofrequency ablation (RFA) were enrolled in 1 of the 2 treatment groups: Dexlansoprazole 60 milligram (mg), once-daily (QD); Dexlansoprazole 60 mg, twice daily (BID).
Arm/Group Title Dexlansoprazole 60 mg QD Dexlansoprazole 60 mg BID
Hide Arm/Group Description Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months. Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
Period Title: Overall Study
Started 3 3
Completed 3 2
Not Completed 0 1
Reason Not Completed
Study termination             0             1
Arm/Group Title Dexlansoprazole 60 mg QD Dexlansoprazole 60 mg BID Total
Hide Arm/Group Description Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months. Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months. Total of all reporting groups
Overall Number of Baseline Participants 3 3 6
Hide Baseline Analysis Population Description
The safety set included all participants who were randomized and received 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 6 participants
70.3  (8.50) 67.7  (6.81) 69.0  (7.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Female
0
   0.0%
1
  33.3%
1
  16.7%
Male
3
 100.0%
2
  66.7%
5
  83.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Not Hispanic or Latino Number Analyzed 3 participants 3 participants 6 participants
3 3 6
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 3 participants 3 participants 6 participants
3 3 6
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 6 participants
3 3 6
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 3 participants 3 participants 6 participants
179.3  (4.04) 167.3  (15.53) 173.3  (12.09)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 3 participants 3 participants 6 participants
96.80  (20.264) 88.83  (8.170) 92.82  (14.491)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 3 participants 3 participants 6 participants
29.95  (4.992) 31.93  (3.212) 30.94  (3.908)
Smoking History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Never smoked 1 0 1
Ever smoked 2 3 5
Number of Smoking Years for Ever Smoked   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
16-20 years 1 1 2
Greater than (>) 20 years 1 2 3
[1]
Measure Description: Baseline measure was analyzed for those participants who have ever smoked tobacco.
Current Smoking Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Non smoker 2 3 5
Smoker 1 0 1
Number of Packs Per Year   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
101-200 packs 1 0 1
301-400 packs 1 0 1
>400 packs 0 1 1
Unknown 0 2 2
[1]
Measure Description: Baseline measure was analyzed in the participants who currently or have ever smoked tobacco.
Alcohol History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Never drank alcohol 2 1 3
Drank alcohol 1 2 3
Number of Drinking Years   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
>20 years 0 1 1
Unknown 1 1 2
[1]
Measure Description: Baseline measure was analyzed for those participants who currently or have ever drank alcohol.
Number of Drinks Per Week   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
0-5 drinks 0 1 1
6-10 drinks 0 1 1
>30 drinks 1 0 1
[1]
Measure Description: Baseline measure was analyzed for those participants who currently or have ever drank alcohol.
Current Alcohol Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Current drinker 0 2 2
Non-drinker 3 1 4
1.Primary Outcome
Title Percentage of Participants With Recurrence of Intestinal Metaplasia (IM)
Hide Description Recurrence of IM was defined as an esophageal biopsy result indicating BE with or without dysplasia.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-treat (ITT) population where Month 12 esophageal biopsy assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.
Arm/Group Title Dexlansoprazole 60 mg QD Dexlansoprazole 60 mg BID
Hide Arm/Group Description:
Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
Overall Number of Participants Analyzed 3 2
Measure Type: Number
Unit of Measure: percentage of participants
0 50
2.Secondary Outcome
Title Percentage of Participants With Recurrence of IM With Dysplasia
Hide Description Recurrence of IM with dysplasia was defined as an esophageal biopsy result indicating BE with dysplasia.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population where Month 12 esophageal biopsy assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.
Arm/Group Title Dexlansoprazole 60 mg QD Dexlansoprazole 60 mg BID
Hide Arm/Group Description:
Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
Overall Number of Participants Analyzed 3 2
Measure Type: Number
Unit of Measure: percentage of participants
0 0
3.Secondary Outcome
Title Percentage of Participants With Erosive Esophagitis (EE)
Hide Description The severity of EE was classified into following grades: Grade A: one or more mucosal breaks no longer than 5 millimeter (mm), none of which extends between the tops of the mucosal folds; Grade B: one or more mucosal breaks more than 5 mm long, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve less than 75 percent (%) of the esophageal circumference; Grade D: mucosal breaks which involve at least 75% of the esophageal circumference.
Time Frame Baseline up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population where EE assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.
Arm/Group Title Dexlansoprazole 60 mg QD Dexlansoprazole 60 mg BID
Hide Arm/Group Description:
Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
Overall Number of Participants Analyzed 3 2
Measure Type: Number
Unit of Measure: percentage of participants
0 0
4.Secondary Outcome
Title Change From Baseline in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Total Score
Hide Description The GERD-HRQL score consisted of 10 questions, where participants were required to answer each question on a scale of 0 to 5 (0: no symptoms; 1: symptoms noticeable but not bothersome; 2: symptoms noticeable and bothersome but not every day; 3: symptoms bothersome every day; 4: symptoms affect daily activity; 5: symptoms are incapacitating to do daily activities). The total score was derived by simply adding the individual score of each question. The total score ranged from 0 to 50 where a higher score indicated more severe disease. The best possible total GERD-HRQL score was 0 (asymptomatic in all questions) and the worst possible score is 50 (incapacitated in all questions).
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.
Arm/Group Title Dexlansoprazole 60 mg QD Dexlansoprazole 60 mg BID
Hide Arm/Group Description:
Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: units on scale
Baseline 7.3  (10.21) 12.0  (10.00)
Change at Month 12 -3.0  (3.00) -11.0  (8.54)
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13).
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Dexlansoprazole 60 mg QD Dexlansoprazole 60 mg BID
Hide Arm/Group Description Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months. Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
All-Cause Mortality
Dexlansoprazole 60 mg QD Dexlansoprazole 60 mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dexlansoprazole 60 mg QD Dexlansoprazole 60 mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   1/3 (33.33%)   2/3 (66.67%) 
Musculoskeletal and connective tissue disorders     
Worsening of back pain  1  1/3 (33.33%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration pneumonia  1 [1]  0/3 (0.00%)  1/3 (33.33%) 
Vascular disorders     
Hypotension  1  0/3 (0.00%)  1/3 (33.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
[1]
The adverse event occurred postcolonoscopy.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dexlansoprazole 60 mg QD Dexlansoprazole 60 mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   2/3 (66.67%) 
Cardiac disorders     
Tachycardia  1  0/3 (0.00%)  1/3 (33.33%) 
Gastrointestinal disorders     
Dyspepsia  1  2/3 (66.67%)  0/3 (0.00%) 
General disorders     
Pyrexia  1  0/3 (0.00%)  1/3 (33.33%) 
Infections and infestations     
Pneumonia  1  1/3 (33.33%)  1/3 (33.33%) 
Sepsis  1  0/3 (0.00%)  1/3 (33.33%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  0/3 (0.00%)  1/3 (33.33%) 
Psychiatric disorders     
Mental status changes  1  0/3 (0.00%)  1/3 (33.33%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/3 (0.00%)  1/3 (33.33%) 
Hypoxia  1  0/3 (0.00%)  1/3 (33.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
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 first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02162758     History of Changes
Other Study ID Numbers: DEX-P4-003
U1111-1152-6767 ( Registry Identifier: WHO )
First Submitted: June 10, 2014
First Posted: June 13, 2014
Results First Submitted: March 31, 2017
Results First Posted: May 11, 2017
Last Update Posted: May 11, 2017