Peptic UlcerPhase 3NCT02084420
Efficacy/Safety Study as H. Pylori Eradication of Triple Therapy for 7 Days Treatment
A Phase 3 study testing Ilaprazole and Pantoprazole in people with Peptic Ulcer, run by Il-Yang Pharm. Co., Ltd. at 18 sites in South Korea.
Trial summary
The purpose of this study is to evaluate of efficacy and safety as H.pylori eradiation effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal ulcer patients with H.pylori positive infection. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Peptic Ulcer
- What is being tested?
- Ilaprazole and Pantoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 18 sitesSouth Korea
- Study dates
- Dec 2012to Jan 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 year old ≤ Male or female < 75 year old
- Patients who had endoscopically confirmed Gastric and/or duodenal ulcer and H.pylori infection confirmed by Urea Breath Test
- Patients who understand the study conditions
- Patients who had been given the explanation about the study, and had provided voluntary written informed consent to participate in the stud
Who cannot join
- Patients with known allergy or hypersensitivity reaction to the Investigational products
- Patients who use the Investigational products
- Patients who undergone H.pylori eradication
- Patients with abnormal laboratory results, as specified below:
- Total bilirubin, creatinine > 1.5 x upper limit of normal Aspartate transminase, Alanine transminase, Alkaline phosphatase, Blood urea nitrogen > 2 x upper limit of normal
- Patients who used Proton Pump Inhibitor agents or antibiotics within the last 2 weeks before the start of the Investigational products
Show all 16Show fewer
- Pregnant women and lactating women
- Women of childbearing potential who were not using a medically acceptable method of contraception during the study period.(Menopausal women who did not have a menstrual period for at least 12 months were considered infertile)
- Patients with uncontrolled Diabetes mellitus
- Patients with uncontrolled Hypertension
- Patients with Alcoholics
- Patients with a history of malignancy within 5 years prior to the study entry (Day 1) (except for basal cell carcinoma of the skin)
- Patients who had undergone a esophageal or gastric surgery
- Patients who had a hereditary disorder as galactose intolerance, lactose intolerance, glucose-galactose malabsorption
- Patients who had participated in other investigational study within 30 days before the study entry (Day 1)
- Patients who, in the investigator's opinion, are not suitable for the study for any other reason
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
South Korea18 sites
Soonchunhang University Hospital
Bucheon-si, Gyeonggi-do
Inje Busan Paik Hospital
Busan
Pusan National University Hospital
Busan
Kyungpook National University Medical Center
Daegu
Yeungnam University Medical Center
Daegu
Konyang University Hospital
Daejeon
Gachon University Gill Medical Center
Incheon
Wonkwang University of Medicine & Hospital
Jeollabuk-do
Chung Ang University Hospital
Seoul
Ewha Womens University Mokdong Hospital
Seoul
Inje University Seoul Paik Hospital
Seoul
Kangbuk Samsung Hospital
Seoul
KyungHee University Medical center
Seoul
Seoul Asan hoapital
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
The Catholic University of Korea, Seoul
Seoul
Wonju Severance Christian Hospital
Wonju-si, Gangwon-do
About this study
Official title: PhaseⅢ Study of A Multicenter, Randomized, Double-blind, Active-controlled to Evaluate of Efficacy /Safety as H. Pylori Eradication Effect Between Ilaprazole/Pantoprazole
The purpose of this study is to evaluate of efficacy and safety as H.pylori eradiation effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal ulcer patients with H.pylori positive infection.
Read the detailed description
This study is to evaluate of efficacy and safety as H.pylori eradiation effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal ulcer patients with H.pylori positive infection.
- Conditions
- Peptic Ulcer
- Being tested
- Ilaprazole, Pantoprazole
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IlaprazoleDrug
Also called NOLTEC
10mg 2 BID( 2 times / day), before breakfast and dinner
PantoprazoleDrug
Also called PANTOLOC
40mg, BID(2 times / day), before breakfast and dinner
| Study group | Role | What they receive |
|---|---|---|
| Ilaprazole or Pantoprazole placebo | Experimental | Ilaprazole 10mg, Pantoprazole 40mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day, PO Receives: Drug: Ilaprazole |
| Ilaprazole placebo or Pantoprazole | Active comparator | Pantoprazole 40mg, Ilaprazole 10mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day,PO Receives: Drug: Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of H.pylori eradication
Measured: participants will be followed at 7 weeks (visit 4)
Secondary outcomes (1)
the rate of Gastric and/or Duodenal ulcer curation
Measured: participants will be followed at 7 weeks (visit 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startDec 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic UlcerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- IL YANG PHARM, Study director, IL-YANG Pharmaceutical Co.LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084420
- Sponsor's protocol ID
- IY-81149-HB03
- Status last verified
- Jun 2014
- First submitted
- 5 Mar 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhaseⅢ Study of A Multicenter, Randomized, Double-blind, Active-controlled to Evaluate of Efficacy /Safety as H. Pylori Eradication Effect Between Ilaprazole/Pantoprazole
- ClinicalTrials.gov ID
- NCT02084420
- Acronym / sponsor ID
- IY-81149-HB03
- Conditions
- Peptic Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate of efficacy and safety as H.pylori eradiation effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal ulcer patients with H.pylori positive infection.
Detailed description
This study is to evaluate of efficacy and safety as H.pylori eradiation effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal ulcer patients with H.pylori positive infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ilaprazole or Pantoprazole placebo | Experimental | Drug: IlaprazoleIlaprazole 10mg, Pantoprazole 40mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day, PO |
| Ilaprazole placebo or Pantoprazole | Active comparator | Drug: PantoprazolePantoprazole 40mg, Ilaprazole 10mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day,PO |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 year old ≤ Male or female < 75 year old
- Patients who had endoscopically confirmed Gastric and/or duodenal ulcer and H.pylori infection confirmed by Urea Breath Test
- Patients who understand the study conditions
- Patients who had been given the explanation about the study, and had provided voluntary written informed consent to participate in the stud
Key exclusion criteria (16 listed)
- Patients with known allergy or hypersensitivity reaction to the Investigational products
- Patients who use the Investigational products
- Patients who undergone H.pylori eradication
- Patients with abnormal laboratory results, as specified below:
- Total bilirubin, creatinine > 1.5 x upper limit of normal Aspartate transminase, Alanine transminase, Alkaline phosphatase, Blood urea nitrogen > 2 x upper limit of normal
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 |
|---|---|---|
| IlaprazoleAlso: NOLTEC10mg 2 BID( 2 times / day), before breakfast and dinner | Drug | Ilaprazole or Pantoprazole placebo |
| PantoprazoleAlso: PANTOLOC40mg, BID(2 times / day), before breakfast and dinner | Drug | Ilaprazole placebo or Pantoprazole |
Primary outcome
the rate of H.pylori eradication
Time frame: participants will be followed at 7 weeks (visit 4)
1 secondary outcome
the rate of Gastric and/or Duodenal ulcer curation
Time frame: participants will be followed at 7 weeks (visit 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
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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.
IL YANG PHARM study director
IL-YANG Pharmaceutical Co.LTD
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ilaprazole and Pantoprazole in people with Peptic Ulcer, run by Il-Yang Pharm. Co., Ltd. at 18 sites in South Korea.
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 4 inclusion and 16 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 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the rate of H.pylori eradication (time frame: participants will be followed at 7 weeks (visit 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2014.