Duodenal UlcerPhase 3NCT00952978
Ilaprazole for the Treatment of Duodenal Ulcer in Chinese Patients (Phase 3)
A Phase 3 study testing 10 mg ilaprazole and 20 mg omeprazole in people with Duodenal Ulcer, run by Livzon Pharmaceutical Group Inc. at 1 site in China.
Trial summary
Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a randomized, double-blind, parallel and positive-controlled trial. They were randomly assigned into two groups, 10 mg/day ilaprazole and 20 mg/day omeprazole, to be treated for up to four weeks and be seen at week 1, 2 and 4. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Duodenal Ulcer
- What is being tested?
- 10 mg ilaprazole and 20 mg omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 496 participants
- Where
- 1 siteChina
- Study dates
- Sep 2005to May 2006
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting patients were eligible for enrollment if they:
- were 18-65 years of age,
- had endoscopically diagnosed active duodenal ulcers within the previous 72 hours and
- the number of ulcers was at least one, but no more than two with the larger diameter 0.3-2.0cm.
Who cannot join
- Patients were ineligible if they:
- had cancerous or complex ulcers, Zollinger-Ellison syndrome, esophageal erosion or ulcer, varices of esophagus or fundus of stomach, or pyloric stenosis,
- had a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation,
- had severe complications (e.g., pyloric obstruction, active bleeding under endoscope), severe other diseases of digestive tract such as Crohn's disease and ulcerative colitis, and severe other systemic diseases,
- were female patients who were breast feeding, pregnant, or intended to become pregnant during the study,
- had taken proton pump inhibitors within the 5 days or for more than three consecutive days within the two weeks immediately preceding start of study drug,
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- participated in a clinical trial with an investigational drug or device within the past three months,
- had hypersensitivity or idiosyncratic reaction to omeprazole or any other benzimidazole,
- had alcoholic intemperance, drug addiction or any other improper habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Ilaprazole for Acute Duodenal Ulcer: A Randomized,Double-Blind,Omeprazole-Controlled,Multicenter,and Phase3 Trial in China
Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a randomized, double-blind, parallel and positive-controlled trial. They were randomly assigned into two groups, 10 mg/day ilaprazole and 20 mg/day omeprazole, to be treated for up to four weeks and be seen at week 1, 2 and 4. The primary endpoint was the ulcer healing rate at week 4. Healing of ulcer was determined by its resolution from active to scarring stage. Symptoms relief was evaluated as secondary end points by using a graded score. Safety and tolerability were evaluated on basis of clinical assessments.
Read the detailed description
The primary endpoint was the healing rate of ulcers, which based on post-treatment (week 4) endoscopic changes in stage of the ulcer relative to baseline (week 0) levels. Stages of the ulcers were endoscopically assessed according to the degree of ulceration, regenerating epithelialization, and scarring, which was defined as follows: A stage (active stage, A1 \& A2) where A1 stage is more severe than A2 stage, H stage (healing stage, H1 \& H2) where H2 stage is better than H1 stage, and S stage (scarring stage, S1 (red scar) \& S2 (white scar)) where S stage is the best stage in the three stages and S2 stage is better than S1.Healing of ulcer is deemed successful if an ulcer in A stage resolved to S stage at the end of the treatment period, regardless of S1 or S2. When endoscopy demonstrated successful ulcer healing, study medication was discontinued. Patients returned at week 2, and if unhealed further endoscopic assessment would be done at week 4. Secondary endpoints included post-treatment resolution of related gastrointestinal symptoms such as upper abdominal pain, heartburn, acid regurgitation, nausea \& vomiting, eructation, and increased flatus. These symptoms were recorded on a scale ranging from 0 to 3(0=none, 1=mild, 2=moderate, 3=severe) at baseline, week 1, 2, and 4. Resolution of symptoms were defined as "excellence", "effective", "improved", or "ineffective" relative to baseline levels, of which complete symptom relief or complete absence of the symptom without recurrence was deemed as "excellence". Safety assessments based mainly on the occurrence, frequency, and severity of adverse events, which were monitored throughout the duration of the study, and also based on comprehensive indexes, including physical examination, electrocardiography, and routine laboratory investigations, which were performed at baseline and repeated at the end of the treatment period. For all adverse events, where necessary, patients were withdrawn from the study.
- Conditions
- Duodenal Ulcer
- Being tested
- 10 mg ilaprazole, 20 mg omeprazole
- Keywords
- Ilaprazole, Proton pump inhibitor, Duodenal ulcer, Acid suppression, Randomized trial
- Medical subject headings
- Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mg ilaprazoleDrug
Two 5-mg ilaprazole tablets(Livzon Pharm Group Inc., China) together with one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks
20 mg omeprazoleDrug
Also called Losec,AstraZeneca
One 20-mg omeprazole capsule (AstraZeneca, Losec) together with two placebo tablets in a package being taken orally each morning on an empty stomach for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 10 mg ilaprazole | Experimental | Not described Receives: Drug: 10 mg ilaprazole |
| 20 mg omeprazole | Active comparator | Not described Receives: Drug: 20 mg omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint was the healing rate of ulcers, which based on post-treatment (week 4) endoscopic changes in stage of the ulcer relative to baseline (week 0) levels.
Measured: week 4
Secondary outcomes (1)
Secondary endpoints included post-treatment resolution of related gastrointestinal symptoms such as nightly pain, heartburn, nightly acid regurgitation, nausea & vomiting, eructation, and increased flatus.
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startSep 2005
- Primary completionFeb 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Duodenal 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
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Livzon Pharmaceutical Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- S R Lin, M.D, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952978
- Sponsor's protocol ID
- Livzon-IY-81149-03
- Other IDs
- 2005L02943
- Status last verified
- Aug 2009
- First submitted
- 5 Aug 2009
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang L, Zhou L, Hu H, Lin S, Xia J. Ilaprazole for the treatment of duodenal ulcer: a randomized, double-blind and controlled phase III trial. Curr Med Res Opin. 2012 Jan;28(1):101-9. doi: 10.1185/03007995.2011.639353. Epub 2012 Jan 3.
PubMed 22070512
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ilaprazole for Acute Duodenal Ulcer: A Randomized,Double-Blind,Omeprazole-Controlled,Multicenter,and Phase3 Trial in China
- ClinicalTrials.gov ID
- NCT00952978
- Acronym / sponsor ID
- Livzon-IY-81149-03
- Conditions
- Duodenal Ulcer
- Keywords
- Ilaprazole, Proton pump inhibitor, Duodenal ulcer, Acid suppression, Randomized trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 6 Aug 2009 (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.
Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a randomized, double-blind, parallel and positive-controlled trial. They were randomly assigned into two groups, 10 mg/day ilaprazole and 20 mg/day omeprazole, to be treated for up to four weeks and be seen at week 1, 2 and 4. The primary endpoint was the ulcer healing rate at week 4. Healing of ulcer was determined by its resolution from active to scarring stage. Symptoms relief was evaluated as secondary end points by using a graded score. Safety and tolerability were evaluated on basis of clinical assessments.
Detailed description
The primary endpoint was the healing rate of ulcers, which based on post-treatment (week 4) endoscopic changes in stage of the ulcer relative to baseline (week 0) levels. Stages of the ulcers were endoscopically assessed according to the degree of ulceration, regenerating epithelialization, and scarring, which was defined as follows: A stage (active stage, A1 \& A2) where A1 stage is more severe than A2 stage, H stage (healing stage, H1 \& H2) where H2 stage is better than H1 stage, and S stage (scarring stage, S1 (red scar) \& S2 (white scar)) where S stage is the best stage in the three stages and S2 stage is better than S1.Healing of ulcer is deemed successful if an ulcer in A stage resolved to S stage at the end of the treatment period, regardless of S1 or S2. When endoscopy demonstrated successful ulcer healing, study medication was discontinued. Patients returned at week 2, and if unhealed further endoscopic assessment would be done at week 4. Secondary endpoints included post-treatment resolution of related gastrointestinal symptoms such as upper abdominal pain, heartburn, acid regurgitation, nausea \& vomiting, eructation, and increased flatus. These symptoms were recorded on a scale ranging from 0 to 3(0=none, 1=mild, 2=moderate, 3=severe) at baseline, week 1, 2, and 4. Resolution of symptoms were defined as "excellence", "effective", "improved", or "ineffective" relative to baseline levels, of which complete symptom relief or complete absence of the symptom without recurrence was deemed as "excellence". Safety assessments based mainly on the occurrence, frequency, and severity of adverse events, which were monitored throughout the duration of the study, and also based on comprehensive indexes, including physical examination, electrocardiography, and routine laboratory investigations, which were performed at baseline and repeated at the end of the treatment period. For all adverse events, where necessary, patients were withdrawn from the study.
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 |
|---|---|---|
| 10 mg ilaprazole | Experimental | Drug: 10 mg ilaprazole |
| 20 mg omeprazole | Active comparator | Drug: 20 mg omeprazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consenting patients were eligible for enrollment if they:
Key exclusion criteria (9 listed)
- Patients were ineligible if they:
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 |
|---|---|---|
| 10 mg ilaprazoleTwo 5-mg ilaprazole tablets(Livzon Pharm Group Inc., China) together with one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks | Drug | 10 mg ilaprazole |
| 20 mg omeprazoleAlso: Losec,AstraZenecaOne 20-mg omeprazole capsule (AstraZeneca, Losec) together with two placebo tablets in a package being taken orally each morning on an empty stomach for 4 weeks | Drug | 20 mg omeprazole |
Primary outcome
The primary endpoint was the healing rate of ulcers, which based on post-treatment (week 4) endoscopic changes in stage of the ulcer relative to baseline (week 0) levels.
Time frame: week 4
1 secondary outcome
Secondary endpoints included post-treatment resolution of related gastrointestinal symptoms such as nightly pain, heartburn, nightly acid regurgitation, nausea & vomiting, eructation, and increased flatus.
Time frame: week 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 6 Aug 2009.
- Derived from this study: PubMed 22070512Wang L, Zhou L, Hu H, Lin S, Xia J. Ilaprazole for the treatment of duodenal ulcer: a randomized, double-blind and controlled phase III trial. Curr Med Res Opin. 2012 Jan;28(1):101-9. doi: 10.1185/03007995.2011.639353. Epub 2012 Jan 3.
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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.
S R Lin, M.D principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10 mg ilaprazole and 20 mg omeprazole in people with Duodenal Ulcer, run by Livzon Pharmaceutical Group Inc. at 1 site in China.
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 9 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 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 primary endpoint was the healing rate of ulcers, which based on post-treatment (week 4) endoscopic changes in stage of the ulcer relative to baseline (week 0) levels. (time frame: week 4). 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 NCT00952978, which also lists 1 linked publication.
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 6 Aug 2009.