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 - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00625274

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).

Condition	Intervention	Phase
Heartburn Upper Abdominal Pain Nausea Acid Regurgitation	Drug: Esomeprazole Drug: Lansoprazole Drug: Pantoprazole	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Abdominal Pain Heartburn Nausea and Vomiting

Drug Information available for: Omeprazole Omeprazole magnesium Pantoprazole Lansoprazole Pantoprazole Sodium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To 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 ]

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 ]

Estimated Enrollment:	100
Study Start Date:	June 2004
Study Completion Date:	November 2004
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Oral	Drug: Esomeprazole 40mg Oral Other Name: Nexium
Experimental: 2 Oral	Drug: Lansoprazole 30mg Oral Other Name: Prevacid
Experimental: 3 Oral	Drug: Pantoprazole 40mg Oral Other Name: Protonix

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625274

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

More Information

No publications provided

Responsible Party:	Tore Lind, MD - Nexium Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00625274 History of Changes
Other Study ID Numbers:	D9612L00063
Study First Received:	February 20, 2008
Last Updated:	February 27, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Nexium
esomeprazole
lansoprazole
pantoprazole
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Additional relevant MeSH terms:

Abdominal Pain
Heartburn
Nausea
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Anti-Inflammatory Agents, Non-Steroidal
Omeprazole
Lansoprazole
Pantoprazole
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Proton Pump Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012