NCT00175045

Brief Summary

The purpose of this study was to compare the pharmacodynamics of intravenous (IV) lansoprazole to oral lansoprazole capsules, once daily (QD), in participants with erosive esophagitis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2003

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

July 21, 2010

Status Verified

July 1, 2010

Enrollment Period

4 months

First QC Date

September 12, 2005

Last Update Submit

July 20, 2010

Conditions

EsophagitisReflux

Keywords

Intravenousgastric acid secretionLansoprazoleEsophagitisreflux

Outcome Measures

Primary Outcomes (1)

  • Maximal Acid Output obtained 22 hours after the last dose of IV lansoprazole compared to the Maximal Acid Output obtained 22 hours after the last dose of oral lansoprazole following pentagastrin stimulation in both instances.

    Day 7 vs Day 15

Secondary Outcomes (3)

  • Basal Acid Output obtained 21 hours after the last dose of IV lansoprazole compared with that obtained 21 hours after the last dose of oral lansoprazole.

    Day 7 vs Day 15

  • Maximum Acid Output and Basal Acid Output measurements obtained 21 hours and 22 hours, respectively, after the first dose of IV lansoprazole versus those obtained after the last dose of oral lansoprazole.

    Day 7 vs Day 8

  • Maximum Acid Output and Basal Acid Output results obtained after the first versus last dose of IV lansoprazole.

    Day 8 vs Day 15

Study Arms (2)

Lansoprazole IV 30 mg QD

EXPERIMENTAL
Drug: Lansoprazole

Lansoprazole Capsule 30 mg QD

ACTIVE COMPARATOR
Drug: Lansoprazole

Interventions

LansoprazoleDRUG

Lansoprazole 30 mg, intravenous injection, once daily for up to 7 days.

Lansoprazole IV 30 mg QD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects were required to have Grade 2, 3 or 4 esophageal findings according to the TAP Grading Scale during the pretreatment endoscopy.
  • Subjects must discontinue histamine H2-receptor antagonists, proton pump ® inhibitors, prokinetic agents, antacids and Carafate before the first dose of drug and during the study.

You may not qualify if:

  • Gastric or duodenal ulcer (a lesion with appreciable depth ≥3 mm) or a hiatal hernia \>5 cm.
  • Subjects could not have a diagnosis of Barrett's esophagus (with or without dysplastic changes).
  • Co-existing systemic disease affecting the esophagus, (ie, scleroderma, viral or fungal infection), radiation therapy to the region of the esophagus, or caustic or physiochemical trauma to the esophagus.
  • Current esophageal stricture requiring dilatation. The endoscope had to pass freely into the stomach during endoscopy. Any strictures could not have been dilated within 12 weeks before beginning the Pretreatment Period.
  • Positive H pylori by rapid urease test (CLO® test Kimberly-Clark Corporation).
  • Uncontrolled, clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, gastrointestinal, neurological or endocrine disease or other abnormality (other than the erosive esophagitis disease being studied).
  • Diagnosis of Zollinger-Ellison syndrome, esophageal varices, symptomatic pancreaticobiliary tract disease, cholecystitis, rheumatoid arthritis, lupus, or malignancy (except basal cell carcinoma).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

EsophagitisGastroesophageal Reflux

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEsophageal Motility DisordersDeglutition Disorders

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Medical Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

June 1, 2003

Primary Completion

October 1, 2003

Study Completion

October 1, 2003

Last Updated

July 21, 2010

Record last verified: 2010-07