Pancreatic DiseasePhase 3CRC2006-05NCT01087801
A Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers
A Phase 3 study testing ChiRhoStim in people with Pancreatic Disease, run by ChiRhoClin, Inc. at 1 site in United States.
Trial summary
The following are the study hypothesis: Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples being predominantly of exocrine pancreas origin when samples are duodenal aspirates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Disease
- What is being tested?
- ChiRhoStim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Dec 2009
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented or suspected diagnosis of chronic pancreatitis or suspected diagnosis of pancreatic cancer.
- Undergoing Endoscopic Procedure.
- Age ≥ 18 years.
- Willing and able to sign informed consent, meeting IRB guidelines.
- Willing and able to meet all study requirements and obligations.
Who cannot join
- Ongoing, active pancreatitis at the time of the procedure.
- Known adverse reaction to secretin.
- Recent (within one month) use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides.
- Use of anticholinergic medication within 7 days of study.
- Pregnant women, nursing mothers, or women of childbearing potential not employing appropriate contraception. Acceptable methods of birth control are: intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive (started at least one month prior to Visit 1 and continuing for the duration of the trial), contraceptive patch, condoms with spermicide or abstinence.
- Any medical condition which in the judgment of the Principal Investigator makes participation of the patient in the study medically unwarranted.
- Known complete obstruction of the pancreatic duct.
- Patients who have received an investigational product/drug or device within 30 days prior to Visit 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo Controlled, Double-Blind, Parallel, Multicenter Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers
The following are the study hypothesis:
- Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples being predominantly of exocrine pancreas origin when samples are duodenal aspirates.
- Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples meeting the minimum specifications for use in the indicated laboratory test of DNA mutational analysis.
- Conditions
- Pancreatic Disease
- Being tested
- ChiRhoStim, Placebo
- Keywords
- Genetic End Marker
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChiRhoStimDrug
Human Secretin for Injection
PlaceboDrug
Saline for Injection
| Study group | Role | What they receive |
|---|---|---|
| ChiRhoStim | Active comparator | Human Secretin for Injection Receives: Drug: ChiRhoStim |
| Placebo | Placebo comparator | Saline for Injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic Sample
Is Volume ≥ 3.5 mL Is HCO3 concentration ≥ 40 mEq/L Is DNA mutational analysis (K-ras-2 gene Fluorescence peak height ≥ 50 Relative Florescence Units panel assessable markers informative ≥ 8).
(Note- The outcome value is boolean (yes or no) as an answer).
Measured: First 5 minutes after treatment administration
Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no).
Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid.
Measured: First 5 minutes after treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startOct 2007
- Primary completionNov 2009
- Study completionDec 2009
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 Pancreatic DiseaseStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- ChiRhoClin, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Burton, M.D., Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087801
- Sponsor's protocol ID
- 2006-05
- Acronym
- CRC2006-05
- Status last verified
- Dec 2011
- First submitted
- 15 Mar 2010
- Last updated
- 6 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled, Double-Blind, Parallel, Multicenter Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers
- ClinicalTrials.gov ID
- NCT01087801
- Acronym / sponsor ID
- CRC2006-05 / 2006-05
- Conditions
- Pancreatic Disease
- Keywords
- Genetic End Marker
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- ChiRhoClin, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Mar 2010 (estimated)
- Results
- Posted 2 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The following are the study hypothesis:
- Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples being predominantly of exocrine pancreas origin when samples are duodenal aspirates.
- Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples meeting the minimum specifications for use in the indicated laboratory test of DNA mutational analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ChiRhoStim | Active comparator | Drug: ChiRhoStimHuman Secretin for Injection |
| Placebo | Placebo comparator | Drug: PlaceboSaline for Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented or suspected diagnosis of chronic pancreatitis or suspected diagnosis of pancreatic cancer.
- Undergoing Endoscopic Procedure.
- Age ≥ 18 years.
- Willing and able to sign informed consent, meeting IRB guidelines.
- Willing and able to meet all study requirements and obligations.
Key exclusion criteria (8 listed)
- Ongoing, active pancreatitis at the time of the procedure.
- Known adverse reaction to secretin.
- Recent (within one month) use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides.
- Use of anticholinergic medication within 7 days of study.
- Pregnant women, nursing mothers, or women of childbearing potential not employing appropriate contraception. Acceptable methods of birth control are: intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive (started at least one month prior to Visit 1 and continuing for the duration of the trial), contraceptive patch, condoms with spermicide or abstinence.
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 |
|---|---|---|
| ChiRhoStimHuman Secretin for Injection | Drug | ChiRhoStim |
| PlaceboSaline for Injection | Drug | Placebo |
Primary outcome
Endoscopic Sample
Time frame: First 5 minutes after treatment administration
Is Volume ≥ 3.5 mL Is HCO3 concentration ≥ 40 mEq/L Is DNA mutational analysis (K-ras-2 gene Fluorescence peak height ≥ 50 Relative Florescence Units panel assessable markers informative ≥ 8). (Note- The outcome value is boolean (yes or no) as an answer).
Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no).
Time frame: First 5 minutes after treatment administration
Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Frank Burton, M.D. principal investigator
St. Louis University
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 ChiRhoStim in people with Pancreatic Disease, run by ChiRhoClin, Inc. at 1 site in United States.
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 5 inclusion and 8 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 Dec 2011. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2011). 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?
Endoscopic Sample (time frame: First 5 minutes after treatment administration). The study lists 2 primary outcomes in all. 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 6 Dec 2011.