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Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study

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ClinicalTrials.gov Identifier: NCT00693225
Recruitment Status : Completed
First Posted : June 6, 2008
Results First Posted : September 20, 2012
Last Update Posted : September 20, 2012
Sponsor:
Collaborator:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Yvonne Romero, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE June 4, 2008
First Posted Date  ICMJE June 6, 2008
Results First Submitted Date  ICMJE August 21, 2012
Results First Posted Date  ICMJE September 20, 2012
Last Update Posted Date September 20, 2012
Study Start Date  ICMJE January 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2008)
We anticipate this study will generate preliminary estimates for the percent of subjects who heal moderate to severe esophagitis with morning vs. bedtime omeprazole/sodium bicarbonate. [ Time Frame: 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2012)
  • 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 ]
    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.
  • 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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2008)
Of those subjects with persistent esophageal erosions following 8 weeks of acid suppression therapy, assess the percent with abnormal acid reflux as detected by 24 hour pH monitoring [ Time Frame: 2 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study
Official Title  ICMJE Impact of Timing on the Efficacy of Omeprazole/Sodium Bicarbonate Zegerid 40 mg in Healing Reflux Esophagitis
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Erosive Esophagitis
Intervention  ICMJE Drug: Omeprazole/sodium bicarbonate
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.
Other Name: Zegerid
Study Arms  ICMJE
  • Active Comparator: Omeprazole/sodium bicarbonate AM dose
    8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
    Intervention: Drug: Omeprazole/sodium bicarbonate
  • Experimental: Omeprazole/sodium bicarbonate PM dose
    8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
    Intervention: Drug: Omeprazole/sodium bicarbonate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2012)
91
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2008)
100
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects who have either moderate to severe erosive esophagitis (Los Angeles grade C or D)
  2. 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.
  3. Subjects able to return to Mayo Clinic Rochester for follow up endoscopy 8 weeks after start of study.
  4. Female subjects are eligible if they are not pregnant or lactating and one of the following criteria is met:

    1. Surgically sterile (by means of hysterectomy or bilateral tubal ligation).
    2. At least one year postmenopausal (no menses for greater than or equal to 12 months).
    3. 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.

Exclusion Criteria:

  1. Subjects already on or failed omeprazole in past, or intolerant of PPI therapy
  2. Subjects who are using clopidogrel (Plavix)
  3. Subjects with one or more of the following diagnoses:

    1. Neoplasm of the esophagus or stomach
    2. Previous upper gastrointestinal surgery (esophagectomy, Heller myotomy, hiatal hernial repair)
    3. Diabetic gastroparesis
    4. Esophageal motility disorder: Achalasia or scleroderma
    5. Zollinger-Ellison syndrome
    6. Infection with human immunodeficiency virus (HIV)
    7. Bleeding diathesis
    8. History of gastric or small bowel obstruction
    9. Inability to read due to blindness, cognitive dysfunction, English language illiteracy
    10. Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss
    11. Pregnant and lactating females will be excluded as PPIs are not thought safe for the fetus (Pregnancy Category C).
  4. 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.
  5. Residence outside of the US (due to difficulties with overseas postal service) or in prison.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00693225
Other Study ID Numbers  ICMJE 07-008503
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Yvonne Romero, Mayo Clinic
Original Responsible Party Yvonne Romero, M.D., Mayo Clinic
Current Study Sponsor  ICMJE Yvonne Romero
Original Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Bausch Health Americas, Inc.
Investigators  ICMJE
Principal Investigator: Yvonne Romero, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP