|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT03079050 |
|
Date of registration:
|
27/02/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan
|
|
Scientific title:
|
An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan |
|
Date of first enrolment:
|
February 27, 2017 |
|
Target sample size:
|
33 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03079050 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Lebanon
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Individuals 18-75 years old
- Fasting in Ramadan
- No daily PPI use
- Individuals willing to sign consent form
- Patients owning a smartphone and able to use a smartphone application
Exclusion Criteria:
- Known erosive GERD on PPI
- Pregnant females
- Prior gastric surgery
- Long standing diabetes mellitus (=10 years of disease)
- Frequent NSAID use (>3x/week)
- Morbid obesity (BMI>35)
- History of recent (<6 months) upper GI bleeding
- Patients who do not own a smartphone or who cannot use a smartphone application
- Known allergy to PPIs
- Known history of poor compliance or adherence and active psychological problems which
might impact adherence
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
GERD
|
|
Proton Pump Inhibitor
|
|
Intervention(s)
|
|
Drug: Dexlansoprazole 60 MG
|
|
Primary Outcome(s)
|
|
Heartburn Relief
[Time Frame: 1 month]
|
|
Secondary Outcome(s)
|
|
Days with relief of nocturnal heartburn symptoms
[Time Frame: 1 month]
|
|
Days with partial relief of heartburn symptoms
[Time Frame: 1 month]
|
|
Side effects/tolerability of Dexlansoprazole 30mg vs. Dexlansoprazole 60mg
[Time Frame: 1 month]
|
|
Improvement in sleep qualit
[Time Frame: 1 month]
|
|
Secondary ID(s)
|
|
IM.AS1.48
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|