Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill

Upper Gastrointestinal Bleeding Clinical Trial

Official title:

Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00045799
• Other study ID #: OSB-IR C03
• Status: Completed
• Phase: Phase 3
• Start date: May 2002
• Est. completion date: May 2003

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.

Description:

This trial will be a triple-blind, double-dummy, prospective, multicenter, randomized clinical trial comparing the effectiveness of OSB-IR to the effectiveness of intravenous cimetidine in preventing upper GI bleeding at risk for SRMD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Patients will be included in the trial if they meet all of the following criteria:

1. An adult or adolescent (greater than or equal to 16 years of age) male or non-pregnant female requiring mechanical ventilation for greater than or equal to 48 hours.

2. An anticipated ICU stay of greater than or equal to 72 hours.

3. An Acute Physiology and Chronic Health Evaluation (APACHE II) score of >11 immediately before randomization.

4. At least one other risk factor for upper GI bleeding due to stress-related mucosal damage in addition to mechanical ventilation. Acceptable "other" risk factors include:

• closed-head injury

• multiple trauma to head, chest, abdomen, solid organs, or limbs

• major surgical procedures (eg, mastectomy, pancreatectomy, cardiovascular surgery) 24 hours previous to screening

• extensive burns (greater than or equal to 30% of the body surface area)

• acute renal failure (urine output <0.5 mL/kg of body weight/hr for one hour, despite adequate fluid resuscitation)

• acid-base disorder (pH less than or equal to 7.3 or base deficit greater than or equal to 5.0 mMol/L with a plasma lactate level >1.5 times the upper limit of normal for the reporting laboratory)

• coagulopathy (a platelet count <50,000/mm3, an INR of >1.5 [i.e., prothrombin time >1.5 times the control value], or a partial-thromboplastin time >2.0 times the control value)

• marked jaundice (defined as plasma total bilirubin concentration of >51.3 micromol/L or >3 mg/dL)

• coma

• hypotension (either a systolic blood pressure <80 mm Hg for 2 hours or more or a decrease of greater than or equal to 30 mm Hg in the systolic blood pressure)

• shock (arterial blood pressure less than or equal to 90 mm Hg or mean arterial pressure less than or equal to 70 mm Hg for at least one hour despite adequate fluid resuscitation, adequate intravascular volume status or the use of vasopressors in an attempt to maintain a systolic blood pressure of greater than or equal to 90 mm Hg or a mean arterial pressure of greater than or equal to 70 mm Hg)

• sepsis (defined as a positively cultured or clinically diagnosed infection with at least three of the following: a body temperature of greater than or equal to 38 degrees C [greater than or equal to 100.4 degrees F] or less than or equal to 36 degrees C [less than or equal to 96.8 degrees F], a heart rate of greater than or equal to 90 beats/min, tachypnea manifested by a respiratory rate of greater than or equal to 20 breaths/min, or hyperventilation as indicated by a PaCO2 of less than or equal to 32 mm Hg, and a white blood cell count of greater than or equal to 12,000 cells/mm3 or less than or equal to 4,000 cells/mm3, or the presence of >10% bands)

5. An intact stomach and a nasogastric or an orogastric tube in place.

6. An anticipation of no enteral feedings for the first two days of trial drug treatment.

Exclusion Criteria

Patients will be excluded from trial participation if they meet any of the following criteria:

1. A status of "No Cardiopulmonary Resuscitation (CPR)".

2. If >48 hours has elapsed since the patient became eligible for the trial.

3. Known history of vagotomy, pyloroplasty, gastroplasty, or any other gastric surgery.

4. Known allergy to cimetidine or omeprazole.

5. Active GI bleeding (including esophageal and gastric variceal bleeding, duodenal and gastric ulcers).

6. Significant risk of swallowing blood (i.e., severe facial trauma, oral lacerations, hemoptysis).

7. Enteral feedings for the first two days of trial drug treatment.

8. Use of an investigational drug within 30 days prior to randomization.

9. Critical/intensive care unit admission following esophageal, gastric, or duodenal surgery or trauma.

10. Known history of upper gastrointestinal lesions that are likely to bleed (e.g., esophageal or gastric varices, gastric polyps, tumors, etc. but excluding patients with gastric or duodenal ulcer disease).

11. Any medical or surgical condition that precludes administration of an oral medication (i.e., OSB-IR).

12. End stage liver disease.

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper Gastrointestinal Bleeding

Intervention

Drug:
• Omeprazole sodium bicarbonate immediate release PWD/FS

• Cimetidine IV

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Akron General Hospital	Akron	Ohio
United States	Protocare Trials	Austell	Georgia
United States	Alta Bates Summit Medical Center	Berkeley	California
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	PAB Clinical Research	Brandon	Florida
United States	SUNY Health Science Center	Brooklyn	New York
United States	Providence St. Joseph's Medical Center	Burbank	California
United States	Verdugo Hills Hospital	Burbank	California
United States	University of Vermont	Burlington	Vermont
United States	Cooper Hospital/UMC	Camden	New Jersey
United States	Duke University Medical Center	Durham	North Carolina
United States	Trinitas Hospital	Elizabeth	New Jersey
United States	Protocare - Alexian Brothers Center for Clinical Research	Elk Grove Village	Illinois
United States	North Texas Affiliated Medical Group	Fort Worth	Texas
United States	Shands Hospital at the University of Florida	Gainesville	Florida
United States	University of Florida	Gainesville	Florida
United States	University of Iowa Health Care	Iowa City	Iowa
United States	Department of Medicine	Kansas City	Kansas
United States	Truman Medical Center Hospital Hill	Kansas City	Missouri
United States	Loma Linda Medical Center	Loma Linda	California
United States	Wellstar Kennestone Hospital	Marietta	Georgia
United States	University of Tennessee	Memphis	Tennessee
United States	Jackson Memorial Hospital	Miami	Florida
United States	Miami VAMC	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	University of Minnesota	Minneapolis	Minnesota
United States	University of South Alabama	Mobile	Alabama
United States	West Virginia University Hospitals, Inc	Morgantown	West Virginia
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Vanderbilt University	Nashville	Tennessee
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Medical Center of LA at New Orleans (LSU Health Sci Ctr)	New Orleans	Louisiana
United States	St. Vincent's Catholic Medical Center	New York	New York
United States	Christiana Hospital	Newark	Delaware
United States	University Hospital	Newark	New Jersey
United States	West Suburban Hospital	Oak Park	Illinois
United States	Texas Tech University Health Sciences Center	Odessa	Texas
United States	University of Nebraska	Omaha	Nebraska
United States	Arizona Pulmonary Specialists	Phoenix	Arizona
United States	Arizona Pulmonary Specialists, Ltd	Phoenix	Arizona
United States	Maricopa Medical Center	Phoenix	Arizona
United States	Oregon Health & Science University	Portland	Oregon
United States	Pulmonary & Critical Care	Richmond	Virginia
United States	University of Rochester Medical Center	Rochester	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Regions Hospital	Saint Paul	Minnesota
United States	Scottsdale Healthcare	Scottsdale	Arizona
United States	Louisiana State University	Shreveport	Louisiana
United States	Baystate Medical Center	Springfield	Massachusetts
United States	St. Johns Hospital	Springfield	Missouri
United States	Stanford University School of Medicine	Stanford	California
United States	USF Pulmonary Research	Tampa	Florida
United States	The Toledo Hospital	Toledo	Ohio
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States,