Acid Peptic DisorderPhase 4NCT01214408
Effect of Digene Total (Buffered Pantoprazole) on 24 Hour Gastric Potential Hydrogen (pH) in Patients From Acid Peptic Disorder After Single and Repeated Dosing.
A Phase 4 study testing Buffered pantoprazole in people with Acid Peptic Disorder, run by Abbott at 1 site in India.
Trial summary
This prospective, open label, single-center and non-comparative study is designed to generate data on Digene Total's (buffered pantoprazole) rapid and sustained gastric acid inhibition effect in patients suffering from acid peptic disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acid Peptic Disorder
- What is being tested?
- Buffered pantoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2011to Jul 2011
- Phase
- Phase 4
- 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
- Adult subjects (18-65 years) suffering from acid peptic disorder (APD), diagnosed endoscopically (reflux esophagitis, gastritis and peptic ulcer)
- Must voluntarily sign and date an informed consent form, approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to any study specific procedures.
- If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control:
- Total abstinence from sexual intercourse (minimum one completed menstrual cycle)
- A vasectomized partner
- Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration.
- Intrauterine device (IUD)
- Double barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or creams)
Who cannot join
- Subjects with concurrent gastrointestinal diseases, gastric surgery, perforation or bleeding
- Subjects who have a history of use of any antisecretory drug within past 7 days prior study Day 0
- Subjects with cardiac, neurological, renal or hepatic dysfunction
- Past history of significant sensitivity or contraindication to study drug
- Pregnant or breast-feeding female
- Any condition that, in the opinion of the Investigator, does not justify the subject's inclusion for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Digene Total on 24 Hrs Ambulatory Gastric ph in Pts Suffering From Acid Peptic Disorder After Single and Repeated Dosing.
This prospective, open label, single-center and non-comparative study is designed to generate data on Digene Total's (buffered pantoprazole) rapid and sustained gastric acid inhibition effect in patients suffering from acid peptic disorders.
- Conditions
- Acid Peptic Disorder
- Being tested
- Buffered pantoprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buffered pantoprazoleDrug
Also called ABT-897, Buffered Pantoprazole, Digene Total
Buffered pantoprazole 40 mg QD
Buffered pantoprazoleDrug
Also called ABT-897, Buffered Pantoprazole, Digene Total
Buffered pantoprazole 40 mg QD
| Study group | Role | What they receive |
|---|---|---|
| GRP-A | Experimental | Not described Receives: Drug: Buffered pantoprazole |
| GRP-B | Experimental | Not described Receives: Drug: Buffered pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken to achieve a gastric pH of > 4 after a single dose of Digene Total (buffered pantoprazole)
Measured: Assessment done on day 1 for group A subjects
Secondary outcomes (2)
Percentage of time gastric pH was > 4 after repeated dosing of Digene Total (buffered pantoprazole)
Measured: Assessment done on day 7 for all subjects
24 hour median gastric pH after repeated dosing of Digene Total (buffered pantoprazole)
Measured: Assessment done on day 1 for group A subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startMar 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acid Peptic DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Balagopal Nair, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214408
- Sponsor's protocol ID
- R12-576
- Status last verified
- Dec 2012
- First submitted
- 3 Oct 2010
- Last updated
- 28 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Digene Total on 24 Hrs Ambulatory Gastric ph in Pts Suffering From Acid Peptic Disorder After Single and Repeated Dosing.
- ClinicalTrials.gov ID
- NCT01214408
- Acronym / sponsor ID
- R12-576
- Conditions
- Acid Peptic Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 5 Oct 2010 (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.
This prospective, open label, single-center and non-comparative study is designed to generate data on Digene Total's (buffered pantoprazole) rapid and sustained gastric acid inhibition effect in patients suffering from acid peptic disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GRP-A | Experimental | Drug: Buffered pantoprazole |
| GRP-B | Experimental | Drug: Buffered pantoprazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult subjects (18-65 years) suffering from acid peptic disorder (APD), diagnosed endoscopically (reflux esophagitis, gastritis and peptic ulcer)
- Must voluntarily sign and date an informed consent form, approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to any study specific procedures.
- If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control:
Key exclusion criteria (6 listed)
- Subjects with concurrent gastrointestinal diseases, gastric surgery, perforation or bleeding
- Subjects who have a history of use of any antisecretory drug within past 7 days prior study Day 0
- Subjects with cardiac, neurological, renal or hepatic dysfunction
- Past history of significant sensitivity or contraindication to study drug
- Pregnant or breast-feeding female
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 |
|---|---|---|
| Buffered pantoprazoleAlso: ABT-897, Buffered Pantoprazole, Digene TotalBuffered pantoprazole 40 mg QD | Drug | GRP-A |
| Buffered pantoprazoleAlso: ABT-897, Buffered Pantoprazole, Digene TotalBuffered pantoprazole 40 mg QD | Drug | GRP-B |
Primary outcome
Time taken to achieve a gastric pH of > 4 after a single dose of Digene Total (buffered pantoprazole)
Time frame: Assessment done on day 1 for group A subjects
2 secondary outcomes
Percentage of time gastric pH was > 4 after repeated dosing of Digene Total (buffered pantoprazole)
Time frame: Assessment done on day 7 for all subjects
24 hour median gastric pH after repeated dosing of Digene Total (buffered pantoprazole)
Time frame: Assessment done on day 1 for group A subjects
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 28 Dec 2012.
- For more information, click on the website linkLink provided by the sponsor.
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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.
Balagopal Nair, MD study director
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buffered pantoprazole in people with Acid Peptic Disorder, run by Abbott at 1 site in India.
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 8 inclusion and 6 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 28 Dec 2012. 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 India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Time taken to achieve a gastric pH of > 4 after a single dose of Digene Total (buffered pantoprazole) (time frame: Assessment done on day 1 for group A subjects). 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 28 Dec 2012.