Gastric or Duodenal UlcersNCT02099682

Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin

An observational study of Gastric or Duodenal Ulcers, run by Takeda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (Takepron) for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin Read more about this study

Who is it for?: Any age
Conditions the study is for: Gastric or Duodenal Ulcers
What is being tested?: Lansoprazole
Type of treatment: Pill or oral medicine
How many people: 3,366 participants
Where: No sites listed yet
Study dates: Aug 2010to Jan 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Gastric or duodenal ulcers

Who may be able to join

(1) Patients with a history of gastric or duodenal ulcers (2) Patients requiring long-term use of low-dose aspirin (81-324 mg once daily) as prophylaxis for thromboembolism (3) Patients taking low-dose oral aspirin (81-324 mg once daily) at the start of administration of lansoprazole (including patients who start low-dose aspirin on the same day as the start of administration of lansoprazole)

Who cannot join

(1) Patients with gastric or duodenal ulcer (in the active [A1, A2] or healing [H1, H2] stage if assessed endoscopically) at the start of administration of lansoprazole (2) Patients with active upper gastrointestinal hemorrhage at the start of administration of lansoprazole (3) Patients with contraindications for lansoprazole

About this study

Official title: Takepron Capsules 15/ Orally Dispersing (OD) Tablets 15 Special Drug Use Surveillance Long-term Use Survey on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin

Read the detailed description

This is a special survey on long-term use (for up to 12 months) of lansoprazole (Takepron) to determine the incidence of adverse drug reactions in the routine clinical setting in patients receiving low-dose aspirin.

The usual adult dosage is 15 mg of lansoprazole administered orally once daily.

Conditions: Gastric or Duodenal Ulcers
Being tested: Lansoprazole
Keywords: Pharmacological therapy
Medical subject headings: Duodenal Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LansoprazoleDrug
Also called Takepron Capsules 15/ OD Tablets
Lansoprazole Capsules 15/ OD Tablets

Study groups in NCT02099682
Study group	Role	What they receive
Lansoprazole 15 mg		Lansoprazole 15 mg orally once daily Receives: Drug: Lansoprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Adverse Drug Reactions
Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Measured: 12 months

Secondary outcomes (7)

Presence or Absence of Endoscopic Examinations
Summary of data on the presence or absence of endoscopic examinations.
Measured: From baseline to 12 months
Presence of Gastric or Duodenal Ulcer
Summary of data on the presence or absence of gastric or duodenal ulcers.
Measured: From baseline to 12 months
Presence of Gastric or Duodenal Hemorrhagic Lesion
Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesions.
Measured: From baseline to 12 months
Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion
Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion.
Measured: From baseline to 12 months
Treatment for Gastric/Duodenal Ulcer or Lesion
Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions.
Measured: From baseline to 12 months
Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions
Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions.
Measured: From baseline to 12 months
Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions
Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions.
Measured: From baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Jan 2014

First posted31 Mar 2014 (estimated)
Study startAug 2010
Primary completionJan 2014
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gastric or Duodenal UlcersStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 3,366 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02099682
Sponsor's protocol ID: 467-712
Other IDs: JapicCTI-142414, JapicCTI-R150735
Status last verified: Sep 2016
First submitted: 26 Mar 2014
Last updated: 4 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Recruiting
Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
Roux-en-y Anastomosis Site, Marginal Ulcer
RecruitingPhase 4
The Bioavailability and Effect on Pouch pH of Esomeprazole After Gastric Bypass
Obesity, Gastric Reflux
Recruiting
The Transit Bipartition With the Use of a Metallic Anastomosis Clip and Circular Fundocorporeal Gastroplication
Type 2 Diabetes Mellitus (T2DM), Obesity & Overweight
RecruitingPhase 1
Compare and Evaluate the Safety and PK Data of a Single Dose Administration of 'AD-115A' or 'AD-1151'
Gastric Ulcer

All Gastric or Duodenal Ulcers trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Takepron Capsules 15/ Orally Dispersing (OD) Tablets 15 Special Drug Use Surveillance Long-term Use Survey on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin
ClinicalTrials.gov ID: NCT02099682
Acronym / sponsor ID: 467-712
Conditions: Gastric or Duodenal Ulcers
Keywords: Pharmacological therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 3,366 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 31 Mar 2014 (estimated)
Results: Posted 25 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The usual adult dosage is 15 mg of lansoprazole administered orally once daily.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Lansoprazole 15 mg	–	Drug: LansoprazoleLansoprazole 15 mg orally once daily

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Gastric or duodenal ulcers

Key inclusion criteria (1 listed)

(1) Patients with a history of gastric or duodenal ulcers (2) Patients requiring long-term use of low-dose aspirin (81-324 mg once daily) as prophylaxis for thromboembolism (3) Patients taking low-dose oral aspirin (81-324 mg once daily) at the start of administration of lansoprazole (including patients who start low-dose aspirin on the same day as the start of administration of lansoprazole)

Key exclusion criteria (1 listed)

(1) Patients with gastric or duodenal ulcer (in the active [A1, A2] or healing [H1, H2] stage if assessed endoscopically) at the start of administration of lansoprazole (2) Patients with active upper gastrointestinal hemorrhage at the start of administration of lansoprazole (3) Patients with contraindications for lansoprazole

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LansoprazoleAlso: Takepron Capsules 15/ OD TabletsLansoprazole Capsules 15/ OD Tablets	Drug	Lansoprazole 15 mg

Primary outcome

Frequency of Adverse Drug Reactions
Time frame: 12 months
Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.

7 secondary outcomes

Presence or Absence of Endoscopic Examinations
Time frame: From baseline to 12 months
Presence of Gastric or Duodenal Ulcer
Time frame: From baseline to 12 months
Presence of Gastric or Duodenal Hemorrhagic Lesion
Time frame: From baseline to 12 months
Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion
Time frame: From baseline to 12 months
Treatment for Gastric/Duodenal Ulcer or Lesion
Time frame: From baseline to 12 months
Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions
Time frame: From baseline to 12 months
Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions
Time frame: From baseline to 12 months

Results and safety

Results posted to the registry on 25 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lansoprazole 15 mg	3,366	3,255

Primary outcome: Frequency of Adverse Drug Reactions

Time frame: 12 months. Number. Unit: participants

Measure	Lansoprazole 15 mg n = 3255
Enteritis infectious	1
Lymphoma	1
Diabetes mellitus	1
Anxiety	1
Dizziness	2
Dysgeusia	1
Headache	1
Loss of consciousness	1

Population analysed: Safety analysis set - All participants who received at least 1 dose of lansoprazole.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose of open-label study drug until 14 days (or 30 days for a serious adverse event) after the last dose of open-label study drug (up to 12 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lansoprazole 15 mg	126 of 3,225 (3.9%)	0 of 3,255 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Gastric or Duodenal Ulcers

Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Recruiting
Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
Roux-en-y Anastomosis Site, Marginal Ulcer
RecruitingPhase 4
The Bioavailability and Effect on Pouch pH of Esomeprazole After Gastric Bypass
Obesity, Gastric Reflux
Recruiting
The Transit Bipartition With the Use of a Metallic Anastomosis Clip and Circular Fundocorporeal Gastroplication
Type 2 Diabetes Mellitus (T2DM), Obesity & Overweight
RecruitingPhase 1
Compare and Evaluate the Safety and PK Data of a Single Dose Administration of 'AD-115A' or 'AD-1151'
Gastric Ulcer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Postmarketing Group Manager study chair

Takeda

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric or Duodenal Ulcers, run by Takeda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Adverse Drug Reactions (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02099682.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016.