Chronic PancreatitisPhase 2NCT01259544
BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency
A Phase 2 study testing benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala) in people with Chronic Pancreatitis and Healthy Volunteers, run by Meridian Bioscience, Inc. at 1 site in India.
Trial summary
13C breath di-peptide tests are an effective non-invasive tool to detect pancreatic exocrine function in patients with Chronic Pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pancreatitis, Healthy Volunteers
- What is being tested?
- benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2009to Mar 2009
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with chronic pancreatitis who meet at least one of the following criteria:
- Adult men or women >18 years of age.
- Endoscopic retrograde cholangiopancreatography (ERCP), magnetic resonance cholangiopancreatography (MRCP), or endoscopic ultrasound demonstrating ductal changes consistent with chronic pancreatitis
- Abnormal secretin pancreatic function test with a peak bicarbonate concentration <80 mEq/L
- Presence of pathogenomic pancreatic calcifications
- Pathology proven chronic pancreatitis on surgical specimens
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- Females of childbearing potential must be willing to use birth control (IUD, oral, transdermal, parenteral contraceptives, or abstinence)
- Patients who can fast for at least 8 hours
- Able to perform the testing and procedures required for the study, as judged by the investigator
- Willing and able to provide written informed consent
Who cannot join
- Failure to obtain consent
- Patients with liver cirrhosis
- Any co-morbid condition with expected survival < 1 year
- History of extensive bowel resection, multiple abdominal surgeries
- Women who are pregnant, breastfeeding, or of childbearing potential and not willing to use methods of birth control
- Uncontrolled diabetes
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- Patients currently receiving total parenteral nutrition (TPN)
- Recipients of an organ transplant
- Patients who have consumed >20cc of alcohol or have taken acetaminophen in the past 24 hours
- History of chronic obstructive pulmonary disease or symptomatic bronchial asthma
- Patients taking drugs that can interfere with 13C di-peptide metabolization
Trial locations and contacts
1 site in 1 country.
India1 site
Asian Institute of Gastroenterology, Hyderabad, India
Somājigūda, Hyderabad, 500 082
About this study
13C breath di-peptide tests are an effective non-invasive tool to detect pancreatic exocrine function in patients with Chronic Pancreatitis.
Read the detailed description
The aim of the study is to assess the pancreatic exocrine insufficiency using a 13C labeled di-peptide breath tests in patients with chronic pancreatitis(CP) and show correlation with secretin stimulated endoscopic Pancreatic Function Test (ePFT). Furthermore, a second purpose is to assess the ability to differentiate between non patients with chronic pancreatitis and those without. Approximately 30 subjects will be tested with both methods within two weeks of each other.
- Conditions
- Chronic Pancreatitis, Healthy Volunteers
- Being tested
- benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)
- Keywords
- CP-Chronic Pancreatitis, DPT-Di peptide breath test, ePFT- Endoscopic pancreatic function test
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)Drug
300 mg of powder form dissolved in one cup of tap water prior to breath test
benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)Drug
300 mg of 13 C di peptide in single dose powder form dissolved in one cup of tap water.
| Study group | Role | What they receive |
|---|---|---|
| Di -petide breath tests and ePFT secretin induced | Active comparator | Di peptide breath tests will be performed on subjects with known chronic pancreatitis Receives: Drug: benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala) |
| c13 di peptide breath tests | Active comparator | Healthy volunteers to compare breath tests results to subjects with chronic pancreatitis Receives: Drug: benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the pancreatic exocrine insufficiency using a 13C labeled di-peptide breath tests in patients with chronic pancreatitis(CP) and show correlation with secretin stimulated endoscopic Pancreatic Function Test (ePFT).
This breath test substrate is new and is hypothesized, based on preliminary studies, that it may be the answer to a much needed non-invasive pancreatic function test. At first stage, it will be compared to the current invasive gold standard: secretin induced ePFT.
Measured: 1 hour
Secondary outcomes (1)
To assess the ability to differentiate between non patients with chronic pancreatitis and those without.
In order to establish the efficacy of this test, it is necessary to confirm that a difference is observed between healthy and non- healthy subjects
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startJan 2009
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Virginia Commonwealth University, Asian Institute of Gastroenterology, Hyderabad, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259544
- Sponsor's protocol ID
- CP-EX-110
- Status last verified
- Dec 2022
- First submitted
- 12 Dec 2010
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency
- ClinicalTrials.gov ID
- NCT01259544
- Acronym / sponsor ID
- CP-EX-110
- Conditions
- Chronic Pancreatitis, Healthy Volunteers
- Keywords
- CP-Chronic Pancreatitis, DPT-Di peptide breath test, ePFT- Endoscopic pancreatic function test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Virginia Commonwealth University, Asian Institute of Gastroenterology, Hyderabad, India
- Study start
- Jan 2009
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Dec 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.
13C breath di-peptide tests are an effective non-invasive tool to detect pancreatic exocrine function in patients with Chronic Pancreatitis.
Detailed description
The aim of the study is to assess the pancreatic exocrine insufficiency using a 13C labeled di-peptide breath tests in patients with chronic pancreatitis(CP) and show correlation with secretin stimulated endoscopic Pancreatic Function Test (ePFT). Furthermore, a second purpose is to assess the ability to differentiate between non patients with chronic pancreatitis and those without. Approximately 30 subjects will be tested with both methods within two weeks of each other.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Di -petide breath tests and ePFT secretin induced | Active comparator | Drug: benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)Di peptide breath tests will be performed on subjects with known chronic pancreatitis |
| c13 di peptide breath tests | Active comparator | Drug: benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)Healthy volunteers to compare breath tests results to subjects with chronic pancreatitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with chronic pancreatitis who meet at least one of the following criteria:
- Females of childbearing potential must be willing to use birth control (IUD, oral, transdermal, parenteral contraceptives, or abstinence)
- Patients who can fast for at least 8 hours
- Able to perform the testing and procedures required for the study, as judged by the investigator
- Willing and able to provide written informed consent
Key exclusion criteria (11 listed)
- Failure to obtain consent
- Patients with liver cirrhosis
- Any co-morbid condition with expected survival < 1 year
- History of extensive bowel resection, multiple abdominal surgeries
- Women who are pregnant, breastfeeding, or of childbearing potential and not willing to use methods of birth control
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 |
|---|---|---|
| benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)300 mg of powder form dissolved in one cup of tap water prior to breath test | Drug | Di -petide breath tests and ePFT secretin induced |
| benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)300 mg of 13 C di peptide in single dose powder form dissolved in one cup of tap water. | Drug | c13 di peptide breath tests |
Primary outcome
To assess the pancreatic exocrine insufficiency using a 13C labeled di-peptide breath tests in patients with chronic pancreatitis(CP) and show correlation with secretin stimulated endoscopic Pancreatic Function Test (ePFT).
Time frame: 1 hour
This breath test substrate is new and is hypothesized, based on preliminary studies, that it may be the answer to a much needed non-invasive pancreatic function test. At first stage, it will be compared to the current invasive gold standard: secretin induced ePFT.
1 secondary outcome
To assess the ability to differentiate between non patients with chronic pancreatitis and those without.
Time frame: 1 hour
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 20 Dec 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala) in people with Chronic Pancreatitis and Healthy Volunteers, run by Meridian Bioscience, Inc. 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 10 inclusion and 11 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 20 Dec 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To assess the pancreatic exocrine insufficiency using a 13C labeled di-peptide breath tests in patients with chronic pancreatitis(CP) and show correlation with secretin stimulated endoscopic Pancreatic Function Test (ePFT). (time frame: 1 hour). 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 20 Dec 2022.