Erosive EsophagitisPhase 4NCT00693225
Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study
A Phase 4 study testing Omeprazole/sodium bicarbonate in people with Erosive Esophagitis, run by Yvonne Romero at 1 site in United States.
Trial summary
The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erosive Esophagitis
- What is being tested?
- Omeprazole/sodium bicarbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have either moderate to severe erosive esophagitis (Los Angeles grade C or D)
- Subjects with esophagitis despite use of a non-omeprazole Proton Pump Inhibitor (PPI)(s) or histamine receptor antagonist (HRA) were invited to participate without a wash-out period.
- Subjects able to return to Mayo Clinic Rochester for follow up endoscopy 8 weeks after start of study.
- Female subjects are eligible if they are not pregnant or lactating and one of the following criteria is met:
- Surgically sterile (by means of hysterectomy or bilateral tubal ligation).
- At least one year postmenopausal (no menses for greater than or equal to 12 months).
- Subject is using a highly effective method of contraception, if of childbearing potential and has a negative urine human chorionic gonadotropin beta subunit (B-HCG) pregnancy test during screening, and prior to trial drug administration.
Who cannot join
- Subjects already on or failed omeprazole in past, or intolerant of PPI therapy
- Subjects who are using clopidogrel (Plavix)
- Subjects with one or more of the following diagnoses:
- Neoplasm of the esophagus or stomach
- Previous upper gastrointestinal surgery (esophagectomy, Heller myotomy, hiatal hernial repair)
- Diabetic gastroparesis
Show all 16Show fewer
- Esophageal motility disorder: Achalasia or scleroderma
- Zollinger-Ellison syndrome
- Infection with human immunodeficiency virus (HIV)
- Bleeding diathesis
- History of gastric or small bowel obstruction
- Inability to read due to blindness, cognitive dysfunction, English language illiteracy
- Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss
- Pregnant and lactating females will be excluded as PPIs are not thought safe for the fetus (Pregnancy Category C).
- Children younger than 18 years of age will be excluded as their compliance might be dictated by others, such as their parents, and their results would not be generalizable to the adult population. Other vulnerable populations, such as those with diminished mental acuity, will be excluded for the same reason.
- Residence outside of the US (due to difficulties with overseas postal service) or in prison.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Timing on the Efficacy of Omeprazole/Sodium Bicarbonate Zegerid 40 mg in Healing Reflux Esophagitis
The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.
Read the detailed description
Hypothesis: The timing of administration of omeprazole/sodium bicarbonate (Zegerid) will impact nocturnal esophageal acid exposure and healing of esophagitis. Specifically, we hypothesize that omeprazole/sodium bicarbonate, taken at bedtime, will be superior in healing esophagitis compared to omeprazole/sodium bicarbonate taken in the morning.
Specific Aim: Compare the percent of subjects with moderate/severe esophagitis who achieve complete endoscopic resolution after 8 weeks of treatment (morning vs. bedtime).
Intervention: All subjects received a one-on-one educational session describing the normal physiology of the upper gastrointestinal tract, the pathophysiology of hiatal hernia and reflux esophagitis, and food stuffs that contribute to reflux, prior to their invitation to participate in the trial. Outpatients who underwent a clinically indicated esophagogastroduodenoscopy (EGD) as advised by their primary health care provider in an open-access endoscopy unit who were diagnosed with Los Angeles grade C or D erosive reflux esophagitis were invited to participate.
Omeprazole/sodium bicarbonate powder for oral suspension 40 mg was supplied in individual packets that are emptied into a small cup containing 15-30 ml (1-2 tablespoons) of water, one per day, for 8 weeks. They were asked to stir well and drink immediately then refill the cup with water and drink. Subjects assigned to morning dosing were instructed to take the medication on an empty stomach, immediately upon rising, 20 to 60 minutes prior to chewing a solid. Subjects assigned to bedtime dosing were instructed to keep the medication by their bedside; taking the medication in a standing or seated upright position immediately before turning off the lights with the intention to sleep. The subject was instructed to not use other liquids or foods for 20 minutes after taking their study medication for those allocated to morning dosing, and until the next morning for those allocated to bedtime dosing.
Gelusil™ was distributed for use as an "on demand" rescue antacid; the frequency of use was recorded with the plan to use Gelusil™ consumption as a potential confounder of omeprazole/sodium bicarbonate efficacy. Other antacids, including sodium bicarbonate, magnesium hydroxide, calcium carbonate, and sucralfate were prohibited. Subjects taking non-omeprazole proton pump inhibitors (PPIs) and/or Histamine Receptor Antagonist (HRAs) were advised to discontinue these medications while they participated in this study. No other medication was altered for this study.
After 8 weeks, a follow-up EGD was performed to assess mucosal integrity by an endoscopist blinded to the study and subject allocation.
- Conditions
- Erosive Esophagitis
- Being tested
- Omeprazole/sodium bicarbonate
- Keywords
- Erosive Esophagitis, Reflux Esophagitis, Gastroesophageal reflux disease, GERD, proton pump inhibitor, omeprazole/sodium bicarbonate
- Medical subject headings
- Esophagitis, Peptic, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeprazole/sodium bicarbonateDrug
Also called Zegerid
Omeprazole/sodium bicarbonate powder for oral suspension 40 mg was supplied in individual packets that were emptied into a small cup containing 15-30 ml (1-2 tablespoons) of water, one per day, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole/sodium bicarbonate AM dose | Active comparator | 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning Receives: Drug: Omeprazole/sodium bicarbonate |
| Omeprazole/sodium bicarbonate PM dose | Experimental | 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime Receives: Drug: Omeprazole/sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects Overall Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment
After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows:
LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up.
Measured: 8 weeks
Secondary outcomes (2)
Percent of Subjects With Moderate Esophagitis (LA Grade C) Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment
After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows:
LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up.
Measured: 8 weeks
Percent of Subjects With Severe Esophagitis (LA Grade D) Who Healed, Improved, or Stayed the Same After 8 Weeks of Treatment
After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows:
LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erosive EsophagitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yvonne Romero
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Sponsor-investigator, Yvonne Romero, Mayo Clinic
- Investigators
- Yvonne Romero, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693225
- Sponsor's protocol ID
- 07-008503
- Status last verified
- Aug 2012
- First submitted
- 4 Jun 2008
- Last updated
- 20 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Timing on the Efficacy of Omeprazole/Sodium Bicarbonate Zegerid 40 mg in Healing Reflux Esophagitis
- ClinicalTrials.gov ID
- NCT00693225
- Acronym / sponsor ID
- 07-008503
- Conditions
- Erosive Esophagitis
- Keywords
- Erosive Esophagitis, Reflux Esophagitis, Gastroesophageal reflux disease, GERD, proton pump inhibitor, omeprazole/sodium bicarbonate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Yvonne RomeroUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Posted 20 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.
Detailed description
Hypothesis: The timing of administration of omeprazole/sodium bicarbonate (Zegerid) will impact nocturnal esophageal acid exposure and healing of esophagitis. Specifically, we hypothesize that omeprazole/sodium bicarbonate, taken at bedtime, will be superior in healing esophagitis compared to omeprazole/sodium bicarbonate taken in the morning.
Specific Aim: Compare the percent of subjects with moderate/severe esophagitis who achieve complete endoscopic resolution after 8 weeks of treatment (morning vs. bedtime).
Intervention: All subjects received a one-on-one educational session describing the normal physiology of the upper gastrointestinal tract, the pathophysiology of hiatal hernia and reflux esophagitis, and food stuffs that contribute to reflux, prior to their invitation to participate in the trial. Outpatients who underwent a clinically indicated esophagogastroduodenoscopy (EGD) as advised by their primary health care provider in an open-access endoscopy unit who were diagnosed with Los Angeles grade C or D erosive reflux esophagitis were invited to participate.
Omeprazole/sodium bicarbonate powder for oral suspension 40 mg was supplied in individual packets that are emptied into a small cup containing 15-30 ml (1-2 tablespoons) of water, one per day, for 8 weeks. They were asked to stir well and drink immediately then refill the cup with water and drink. Subjects assigned to morning dosing were instructed to take the medication on an empty stomach, immediately upon rising, 20 to 60 minutes prior to chewing a solid. Subjects assigned to bedtime dosing were instructed to keep the medication by their bedside; taking the medication in a standing or seated upright position immediately before turning off the lights with the intention to sleep. The subject was instructed to not use other liquids or foods for 20 minutes after taking their study medication for those allocated to morning dosing, and until the next morning for those allocated to bedtime dosing.
Gelusil™ was distributed for use as an "on demand" rescue antacid; the frequency of use was recorded with the plan to use Gelusil™ consumption as a potential confounder of omeprazole/sodium bicarbonate efficacy. Other antacids, including sodium bicarbonate, magnesium hydroxide, calcium carbonate, and sucralfate were prohibited. Subjects taking non-omeprazole proton pump inhibitors (PPIs) and/or Histamine Receptor Antagonist (HRAs) were advised to discontinue these medications while they participated in this study. No other medication was altered for this study.
After 8 weeks, a follow-up EGD was performed to assess mucosal integrity by an endoscopist blinded to the study and subject allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omeprazole/sodium bicarbonate AM dose | Active comparator | Drug: Omeprazole/sodium bicarbonate8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning |
| Omeprazole/sodium bicarbonate PM dose | Experimental | Drug: Omeprazole/sodium bicarbonate8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who have either moderate to severe erosive esophagitis (Los Angeles grade C or D)
- Subjects with esophagitis despite use of a non-omeprazole Proton Pump Inhibitor (PPI)(s) or histamine receptor antagonist (HRA) were invited to participate without a wash-out period.
- Subjects able to return to Mayo Clinic Rochester for follow up endoscopy 8 weeks after start of study.
- Female subjects are eligible if they are not pregnant or lactating and one of the following criteria is met:
Key exclusion criteria (16 listed)
- Subjects already on or failed omeprazole in past, or intolerant of PPI therapy
- Subjects who are using clopidogrel (Plavix)
- Subjects with one or more of the following diagnoses:
- Children younger than 18 years of age will be excluded as their compliance might be dictated by others, such as their parents, and their results would not be generalizable to the adult population. Other vulnerable populations, such as those with diminished mental acuity, will be excluded for the same reason.
- Residence outside of the US (due to difficulties with overseas postal service) or in prison.
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 |
|---|---|---|
| Omeprazole/sodium bicarbonateAlso: ZegeridOmeprazole/sodium bicarbonate powder for oral suspension 40 mg was supplied in individual packets that were emptied into a small cup containing 15-30 ml (1-2 tablespoons) of water, one per day, for 8 weeks. | Drug | Omeprazole/sodium bicarbonate AM dose, Omeprazole/sodium bicarbonate PM dose |
Primary outcome
Percent of Subjects Overall Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment
Time frame: 8 weeks
After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows: LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up.
2 secondary outcomes
Percent of Subjects With Moderate Esophagitis (LA Grade C) Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment
Time frame: 8 weeks
Percent of Subjects With Severe Esophagitis (LA Grade D) Who Healed, Improved, or Stayed the Same After 8 Weeks of Treatment
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Yvonne Romero, M.D. principal investigator
Mayo Clinic
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 Omeprazole/sodium bicarbonate in people with Erosive Esophagitis, run by Yvonne Romero at 1 site in United States.
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 7 inclusion and 16 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 20 Sep 2012. 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 United States. 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?
Yes. Results are posted in the registry (first posted 20 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Subjects Overall Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2012.