A Randomized, Open-Label, Comparative 3-Way Treatment Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40mg, Lansoprazole 30mg, and Pantoprazole 40mg at Steady State in NSAID-Using Patients

Overview[ - collapse ][ - ]

Purpose This study looks at controlling intragastric pH following administration of esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg taken orally, once daily in patients taking either non-selective or cyclooxygenase-2 (COX-2) selective nonsteroidal anti-inflammatory drugs (NSAIDs).
ConditionHeartburn
Upper Abdominal Pain
Nausea
Acid Regurgitation
InterventionDrug: Esomeprazole
Drug: Lansoprazole
Drug: Pantoprazole
PhasePhase 4
SponsorAstraZeneca
Responsible PartyAstraZeneca
ClinicalTrials.gov IdentifierNCT00625274
First ReceivedFebruary 20, 2008
Last UpdatedFebruary 27, 2008
Last verifiedFebruary 2008

Tracking Information[ + expand ][ + ]

First Received DateFebruary 20, 2008
Last Updated DateFebruary 27, 2008
Start DateJune 2004
Estimated Primary Completion DateNovember 2004
Current Primary Outcome MeasuresTo compare the pharmacodynamic efficacy in controlling intragastric pH (percent time pH > 4.0) following administration of esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg taken orally, once daily in pat [Time Frame: Screening, assessments every 2 weeks.] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • To compare nocturnal intragastric acid control in NSAID-using patients taking esomeprazole 40 mg, lansoprazole 30 mg or pantoprazole 40 mg once daily. [Time Frame: Patients will be an in-patient beginning the AM of Day 5 through the AM of Day 6 during all three treatment periods.] [Designated as safety issue: No]
  • To compare intragastric acid control utilizing thresholds other than pH 4.0 among NSAID-using patients taking esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg once daily. [Time Frame: Patients will be an in-patient beginning the AM of Day 5 through the AM of Day 6 during all three treatment periods.] [Designated as safety issue: No]
  • To compare the mean hourly cumulative integrated gastric acidity during the 24-hour monitoring period on Day 5 among NSAID-using patients taking esomeprazole 40 mg, lansoprazole 30mg and pantoprazole 40 mg once daily. [Time Frame: 24-hour monitoring period] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleA Randomized, Open-Label, Comparative 3-Way Treatment Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40mg, Lansoprazole 30mg, and Pantoprazole 40mg at Steady State in NSAID-Using Patients
Official TitleNot Provided
Brief Summary
This study looks at controlling intragastric pH following administration of esomeprazole 40
mg, lansoprazole 30 mg and pantoprazole 40 mg taken orally, once daily in patients taking
either non-selective or cyclooxygenase-2 (COX-2) selective nonsteroidal anti-inflammatory
drugs (NSAIDs).
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Heartburn
  • Upper Abdominal Pain
  • Nausea
  • Acid Regurgitation
InterventionDrug: Esomeprazole
40mg Oral
Other Names:
NexiumDrug: Lansoprazole
30mg Oral
Other Names:
PrevacidDrug: Pantoprazole
40mg Oral
Other Names:
Protonix
Study Arm (s)
  • Experimental: 1
    Oral
  • Experimental: 2
    Oral
  • Experimental: 3
    Oral

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment100
Estimated Completion DateNovember 2004
Estimated Primary Completion DateNovember 2004
Eligibility Criteria
Inclusion Criteria:

- A medical diagnosis of a condition that requires daily Nonsteroidal Anti-Inflammatory
Drugs (NSAID) treatment for at least 5 days per week for 1 month prior to entering
the study and during the study.

- Some patients will need to undergo an upper endoscopy at screening.

Exclusion Criteria:

- Signs of clinically significant (GI) bleeding (e.g., melena, frank hematochezia) at
the time of the baseline EGD or within 3 days prior to randomization.

- History of gastric or esophageal surgery (including but not limited to Nissen
fundoplication, bariatric surgery (e.g. gastric stapling or Roux-En-Y gastric
bypass), vagotomy, or Billroth operation).

- Many further exclusion criteria, please refer to the investigator site.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00625274
Other Study ID NumbersD9612L00063
Has Data Monitoring CommitteeNot Provided
Information Provided ByAstraZeneca
Study SponsorAstraZeneca
CollaboratorsNot Provided
Investigators Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca
Verification DateFebruary 2008