NCT02151786

Brief Summary

The purpose of this survey is to evaluate the safety (i.e., frequency of adverse events) and efficacy (i.e., hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of lansoprazole intravenous 30 milligram (mg) (Takepron Intravenous 30 mg) to a large number of patients in daily medical practice.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,120

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

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

January 1, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 23, 2016

Completed
Last Updated

February 23, 2016

Status Verified

January 1, 2016

Enrollment Period

3.2 years

First QC Date

May 28, 2014

Results QC Date

January 24, 2016

Last Update Submit

January 24, 2016

Conditions

Gastric Ulcer, Duodenal Ulcer, Acute Stress Gastritis, and Acute Gastric Mucosal Lesions

Keywords

Pharmacological therapy

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Reporting One or More Adverse Drug Reactions

    Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

    Baseline up to Week 9

  • Number of Participants Reporting One or More Serious Adverse Drug Reactions

    Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    Baseline up to Week 9

Secondary Outcomes (6)

  • Percentage of Participants With Observed Hemostatic Effect

    Baseline up to Week 9

  • Percentage of Participants With Confirmed Hemostatic Effect

    Baseline up to Week 9

  • Percentage of Participants Who Experienced Rebleeding After Observed Hemostatic Effect

    Baseline up to Week 9

  • Percentage of Participants Who Experienced Rebleeding After Confirmed Hemostatic Effect

    Baseline up to Week 9

  • Percentage of Participants With Observed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment

    Week 8 after the last dose of study drug (Week 17)

  • +1 more secondary outcomes

Study Arms (1)

Thirty milligrams of lansoprazole

Thirty milligrams of lansoprazole is mixed in physiological saline (JP) or 5 percent (%) glucose solution for injection (JP) and administered twice daily by drip infusion or dissolved in 20 milliliter (mL) of physiological saline (JP) or 5% glucose solution for injection (JP) and administered twice daily by direct slow intravenous injection.

Drug: Lansoprazole

Interventions

LansoprazoleDRUG

Lansoprazole intravenous 30 mg

Also known as: Takepron Intravenous 30 mg
Thirty milligrams of lansoprazole

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Gastric ulcer, duodenal ulcer, acute stress gastritis, and acute gastric mucosal lesions

You may qualify if:

  • Patients with the following diseases for whom oral administration is not feasible:
  • Gastric ulcer, duodenal ulcer, acute stress gastritis, and acute gastric mucosal lesion (all of which should be accompanied by bleeding).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach UlcerDuodenal Ulcer

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Medical Director
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Postmarketing Group Manager

    Takeda

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2014

First Posted

May 30, 2014

Study Start

January 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

February 23, 2016

Results First Posted

February 23, 2016

Record last verified: 2016-01