GERDPhase 4NCT03079050
An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan
A Phase 4 study testing Dexlansoprazole 60 MG in people with GERD and Proton Pump Inhibitor, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Dexlansoprazole modified release (MR), the R-enantiomer of Lansoprazole, is an FDA approved drug (2009) for the management of erosive esophagitis and nonerosive reflux disease 1. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- GERD, Proton Pump Inhibitor
- What is being tested?
- Dexlansoprazole 60 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteLebanon
- Study dates
- 27 Feb 2017to 30 Jul 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Dexlansoprazole modified release (MR), the R-enantiomer of Lansoprazole, is an FDA approved drug (2009) for the management of erosive esophagitis and nonerosive reflux disease 1. Dexlansoprazole has a unique dual delayed-release delivery system designed to address unmet needs that may accompany traditional proton pump inhibitors, with two separate pH-depended release phases, the first in the proximal duodenum and the second in the more distal small intestine. This dual release system extends the plasma concentration and pharmacodynamics effects beyond those of single-release PPIs, allowing for dosing at any time of the day without regard to meals 1. A study conducted by Fass et al. has shown that the use of dexlansoprazole MR 30 mg in patients with symptomatic GERD is significantly more effective than placebo in improving nocturnal heartburn, reducing GERD-related sleep disturbances, and consequently improving work productivity, sleep quality and quality of life 2.
Because of its pharmacokinetic properties, Dexlansoprazole modified release (MR) may prove beneficial in optimizing the management of GERD and the associated burdens that often surface after the heavy evening and Suhur meals, such as increased nocturnal symptoms and poor sleep quality.
Read the detailed description
To investigate the efficacy and quality of life improvement of Dexlansoprazole 60mg taken once daily at Iftar time in patients with known symptomatic heartburn exacerbated in Ramadan and who are not on daily treatment.
- Conditions
- GERD, Proton Pump Inhibitor
- Being tested
- Dexlansoprazole 60 MG
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexlansoprazole 60 MGDrug
Also called Dexilant 60 MG
This drug will be given to 34 random patients during the 2nd, 3rd, and 4th weeks of the month of Ramadan to assess its ability to relieve GERD symptoms
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 34 patients will be assigned to take Dexlansoprazole 60mg over the 2nd, 3rd, and 4th weeks of the month of Ramadan. Receives: Drug: Dexlansoprazole 60 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heartburn Relief
The mean number of days during Ramadan with complete relief of heartburn symptoms, including nocturnal symptoms.
Measured: 1 month
Secondary outcomes (4)
Days with partial relief of heartburn symptoms
Days with partial relief of heartburn symptoms
Measured: 1 month
Days with relief of nocturnal heartburn symptoms
Days with relief of nocturnal heartburn symptoms
Measured: 1 month
Improvement in sleep qualit
The number of nocturnal sleeping hours will be assessed daily
Measured: 1 month
Side effects/tolerability of Dexlansoprazole 30mg vs. Dexlansoprazole 60mg
"Side effects and tolerability" Questionnaire
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start27 Feb 2017
- Primary completion30 Jul 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for GERDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079050
- Sponsor's protocol ID
- IM.AS1.48
- Status last verified
- Feb 2017
- First submitted
- 27 Feb 2017
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Behm BW, Peura DA. Dexlansoprazole MR for the management of gastroesophageal reflux disease. Expert Rev Gastroenterol Hepatol. 2011 Aug;5(4):439-45. doi: 10.1586/egh.11.37.
PubMed 21780890Fass R, Johnson DA, Orr WC, Han C, Mody R, Stern KN, Pilmer BL, Perez MC. The effect of dexlansoprazole MR on nocturnal heartburn and GERD-related sleep disturbances in patients with symptomatic GERD. Am J Gastroenterol. 2011 Mar;106(3):421-31. doi: 10.1038/ajg.2010.458. Epub 2011 Jan 11.
PubMed 21224838Fass R, Inadomi J, Han C, Mody R, O'Neil J, Perez MC. Maintenance of heartburn relief after step-down from twice-daily proton pump inhibitor to once-daily dexlansoprazole modified release. Clin Gastroenterol Hepatol. 2012 Mar;10(3):247-53. doi: 10.1016/j.cgh.2011.11.021. Epub 2011 Dec 7.
PubMed 22155561Solem C, Mody R, Stephens J, Macahilig C, Gao X. Mealtime-related dosing directions for proton-pump inhibitors in gastroesophageal reflux disease: physician knowledge, patient adherence. J Am Pharm Assoc (2003). 2014 Mar-Apr;54(2):144-53. doi: 10.1331/JAPhA.2014.13117.
PubMed 24632930Kahrilas PJ, Shaheen NJ, Vaezi MF, Hiltz SW, Black E, Modlin IM, Johnson SP, Allen J, Brill JV; American Gastroenterological Association. American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008 Oct;135(4):1383-1391, 1391.e1-5. doi: 10.1053/j.gastro.2008.08.045. No abstract available.
PubMed 18789939Abbas Z. Gastrointestinal health in Ramadan with special reference to diabetes. J Pak Med Assoc. 2015 May;65(5 Suppl 1):S68-71.
PubMed 26013794Rimmani HH, Rustom LBO, Rahal MA, Shayto RH, Chaar H, Sharara AI. Dexlansoprazole is Effective in Relieving Heartburn during the Fasting Month of Ramadan. Dig Dis. 2019;37(3):188-193. doi: 10.1159/000496091. Epub 2019 Jan 9.
PubMed 30625462
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan
- ClinicalTrials.gov ID
- NCT03079050
- Acronym / sponsor ID
- IM.AS1.48
- Conditions
- GERD, Proton Pump Inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dexlansoprazole modified release (MR), the R-enantiomer of Lansoprazole, is an FDA approved drug (2009) for the management of erosive esophagitis and nonerosive reflux disease 1. Dexlansoprazole has a unique dual delayed-release delivery system designed to address unmet needs that may accompany traditional proton pump inhibitors, with two separate pH-depended release phases, the first in the proximal duodenum and the second in the more distal small intestine. This dual release system extends the plasma concentration and pharmacodynamics effects beyond those of single-release PPIs, allowing for dosing at any time of the day without regard to meals 1. A study conducted by Fass et al. has shown that the use of dexlansoprazole MR 30 mg in patients with symptomatic GERD is significantly more effective than placebo in improving nocturnal heartburn, reducing GERD-related sleep disturbances, and consequently improving work productivity, sleep quality and quality of life 2.
Because of its pharmacokinetic properties, Dexlansoprazole modified release (MR) may prove beneficial in optimizing the management of GERD and the associated burdens that often surface after the heavy evening and Suhur meals, such as increased nocturnal symptoms and poor sleep quality.
Detailed description
To investigate the efficacy and quality of life improvement of Dexlansoprazole 60mg taken once daily at Iftar time in patients with known symptomatic heartburn exacerbated in Ramadan and who are not on daily treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Dexlansoprazole 60 MG34 patients will be assigned to take Dexlansoprazole 60mg over the 2nd, 3rd, and 4th weeks of the month of Ramadan. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Known erosive GERD on PPI
- Pregnant females
- Prior gastric surgery
- Long standing diabetes mellitus (≥10 years of disease)
- Frequent NSAID use (>3x/week)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexlansoprazole 60 MGAlso: Dexilant 60 MGThis drug will be given to 34 random patients during the 2nd, 3rd, and 4th weeks of the month of Ramadan to assess its ability to relieve GERD symptoms | Drug | 1 |
Primary outcome
Heartburn Relief
Time frame: 1 month
The mean number of days during Ramadan with complete relief of heartburn symptoms, including nocturnal symptoms.
4 secondary outcomes
Days with partial relief of heartburn symptoms
Time frame: 1 month
Days with relief of nocturnal heartburn symptoms
Time frame: 1 month
Improvement in sleep qualit
Time frame: 1 month
Side effects/tolerability of Dexlansoprazole 30mg vs. Dexlansoprazole 60mg
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Background: PubMed 21780890Behm BW, Peura DA. Dexlansoprazole MR for the management of gastroesophageal reflux disease. Expert Rev Gastroenterol Hepatol. 2011 Aug;5(4):439-45. doi: 10.1586/egh.11.37.
- Background: PubMed 21224838Fass R, Johnson DA, Orr WC, Han C, Mody R, Stern KN, Pilmer BL, Perez MC. The effect of dexlansoprazole MR on nocturnal heartburn and GERD-related sleep disturbances in patients with symptomatic GERD. Am J Gastroenterol. 2011 Mar;106(3):421-31. doi: 10.1038/ajg.2010.458. Epub 2011 Jan 11.
- Background: PubMed 22155561Fass R, Inadomi J, Han C, Mody R, O'Neil J, Perez MC. Maintenance of heartburn relief after step-down from twice-daily proton pump inhibitor to once-daily dexlansoprazole modified release. Clin Gastroenterol Hepatol. 2012 Mar;10(3):247-53. doi: 10.1016/j.cgh.2011.11.021. Epub 2011 Dec 7.
- Background: PubMed 24632930Solem C, Mody R, Stephens J, Macahilig C, Gao X. Mealtime-related dosing directions for proton-pump inhibitors in gastroesophageal reflux disease: physician knowledge, patient adherence. J Am Pharm Assoc (2003). 2014 Mar-Apr;54(2):144-53. doi: 10.1331/JAPhA.2014.13117.
- Background: PubMed 18789939Kahrilas PJ, Shaheen NJ, Vaezi MF, Hiltz SW, Black E, Modlin IM, Johnson SP, Allen J, Brill JV; American Gastroenterological Association. American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008 Oct;135(4):1383-1391, 1391.e1-5. doi: 10.1053/j.gastro.2008.08.045. No abstract available.
- Background: PubMed 26013794Abbas Z. Gastrointestinal health in Ramadan with special reference to diabetes. J Pak Med Assoc. 2015 May;65(5 Suppl 1):S68-71.
- Derived from this study: PubMed 30625462Rimmani HH, Rustom LBO, Rahal MA, Shayto RH, Chaar H, Sharara AI. Dexlansoprazole is Effective in Relieving Heartburn during the Fasting Month of Ramadan. Dig Dis. 2019;37(3):188-193. doi: 10.1159/000496091. Epub 2019 Jan 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexlansoprazole 60 MG in people with GERD and Proton Pump Inhibitor, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heartburn Relief (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03079050, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.