Chronic PancreatitisPhase 1/2NCT01265875
Secretin Infusion for Pain Due to Chronic Pancreatitis
A Phase 1/2 study testing Human Secretin in people with Chronic Pancreatitis, run by ChiRhoClin, Inc. at 1 site in United States.
Trial summary
To determine if intravenous secretin administration in escalating doses three times daily for three days will improve the pain from CP at the time of infusion, after each infusion (1 to 3 hours), at Day 7 after infusion, and at Day 30 after infusion. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Human Secretin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Apr 2012
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, between the ages of 18-70 years old.
- Documented chronic pancreatitis as determined by CT scan, endoscopic ultrasound, MRCP and/or pancreatic function tests.
- If female, and not more than 1 year post-menopausal or surgically sterile, must use medically acceptable form of contraception or abstain from sexual activity during the study. Acceptable methods of birth control are: intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive (started at least one month prior to Screening Visit 1 and continuing for the duration of the trial), contraceptive patch, condoms with spermicide or abstinence.
- If a female of reproductive potential, receive counseling on pregnancy protection and effective contraception within 30 days prior to dosing with secretin.
- Negative serum pregnancy within 72 hours of secretin administration.
- Use of opioid analgesics for chronic pain from CP.
- Willing and able to sign written informed consent.
Who cannot join
- Male or female <18 or >70 years of age.
- Abnormal serum amylase and/or lipase indicative of acute pancreatitis within 30 days of study enrollment.
- Exhibiting signs and/or symptoms of an episode of acute pancreatitis.
- Severe cardiac disease (stable or unstable angina, congestive heart failure, uncontrolled arrhythmias, implantable defibrillator, severe valvular disease, etc).
- Severe pulmonary disease (COPD, severe asthma, interstitial lung disease, etc).
- Severe renal disease (history of acute or chronic renal failure, dialysis dependent, baseline creatinine >2.0 mg/dL).
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- Previous adverse drug event to intravenous secretin.
- Ongoing illicit drug use or abuse.
- Ongoing moderate or severe alcohol use defined as greater than 8 oz beer, 8 oz wine and/or 1 oz liquor /day.
- Acute pancreatitis as defined by the Atlanta Classification definition (refer to Table 1) within the previous two months or symptoms consistent with ongoing acute pancreatitis.
- Prior pancreatic surgery.
- Pregnant women, nursing mothers, or women of childbearing potential not employing appropriate contraception.
- Use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides within 30 days prior to Visit 1.
- Any medical condition which, in the judgment of the investigator, renders participation in this study medically inadvisable.
- Participation in an investigational clinical study for a drug or medical device within 30 days prior to Visit 1.
- Unwilling or unable to give written, informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
- To determine if intravenous secretin administration in escalating doses three times daily for three days will improve the pain from CP at the time of infusion, after each infusion (1 to 3 hours), at Day 7 after infusion, and at Day 30 after infusion.
- To validate the safety of intravenous secretin administration at the dosage indicated in this study.
Read the detailed description
12 patients will be enrolled in this study. Patients will be only those treated at Dartmouth-Hitchcock Medical Center for the diagnosis of CP. The diagnosis of CP will be made by the PI based on standard clinical, radiographic and/or biochemical criteria. Patients must be taking prescribed opioid analgesics for the specific treatment of CP at the time of study enrollment. Only patients between the ages of 18-70 and capable of providing informed consent will be considered eligible for the study.
- Conditions
- Chronic Pancreatitis
- Being tested
- Human Secretin
- Keywords
- Chronic Pancreatitis
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human SecretinDrug
Also called ChiRhoStim
Dose Escalation
| Study group | Role | What they receive |
|---|---|---|
| human secretin | Other | intravenous secretin administration in escalating doses three times daily for three days. After each infusion (1 to 3 hours), at Day 7 after infusion, and at Day 30 after infusion. Receives: Drug: Human Secretin |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
10 point visual analog scale. 0= no pain. 10= worst possible pain. Days 1, 2, 3 were infusion days that included 5 VAS scores each day.
Measured: Baseline, Days 1, 2, 3, 4, 7, 30.
Opiate Use at Baseline, Days 4 and 30.
Daily opiate use (oral morphine equivalent).
Measured: Baseline, Day 4, Day 30.
Quality of Life at Baseline, Day 4 and Day 30.
Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes.
Measured: Baseline, Day 4, Day 30.
Secondary outcomes (2)
Number of Participants With Serious Adverse Events.
Measured: 30 Days
VAS Score at Each Administered Dose.
10 point scare from 0-10 with higher scores meaning higher levels of pain. VAS score assessed after each dose was summarized over Days 1, 2, and 3.
Measured: Days 1, 2, and 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2011
- Study completionApr 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- ChiRhoClin, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dartmouth-Hitchcock Medical Center
- Responsible party
- Sponsor
- Investigators
- Timothy B Gardner, M.D., Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265875
- Sponsor's protocol ID
- 2010-01
- Status last verified
- Mar 2016
- First submitted
- 22 Dec 2010
- Last updated
- 9 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Levenick JM, Andrews CL, Purich ED, Gordon SR, Gardner TB. A phase II trial of human secretin infusion for refractory type B pain in chronic pancreatitis. Pancreas. 2013 May;42(4):596-600. doi: 10.1097/MPA.0b013e318273f3ec.
PubMed 23548879
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secretin Infusion for Pain Due to Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT01265875
- Acronym / sponsor ID
- 2010-01
- Conditions
- Chronic Pancreatitis
- Keywords
- Chronic Pancreatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ChiRhoClin, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Dartmouth-Hitchcock Medical Center
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 23 Dec 2010 (estimated)
- Results
- Posted 1 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To determine if intravenous secretin administration in escalating doses three times daily for three days will improve the pain from CP at the time of infusion, after each infusion (1 to 3 hours), at Day 7 after infusion, and at Day 30 after infusion.
- To validate the safety of intravenous secretin administration at the dosage indicated in this study.
Detailed description
12 patients will be enrolled in this study. Patients will be only those treated at Dartmouth-Hitchcock Medical Center for the diagnosis of CP. The diagnosis of CP will be made by the PI based on standard clinical, radiographic and/or biochemical criteria. Patients must be taking prescribed opioid analgesics for the specific treatment of CP at the time of study enrollment. Only patients between the ages of 18-70 and capable of providing informed consent will be considered eligible for the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| human secretin | Other | Drug: Human Secretinintravenous secretin administration in escalating doses three times daily for three days. After each infusion (1 to 3 hours), at Day 7 after infusion, and at Day 30 after infusion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, between the ages of 18-70 years old.
- Documented chronic pancreatitis as determined by CT scan, endoscopic ultrasound, MRCP and/or pancreatic function tests.
- If female, and not more than 1 year post-menopausal or surgically sterile, must use medically acceptable form of contraception or abstain from sexual activity during the study. Acceptable methods of birth control are: intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive (started at least one month prior to Screening Visit 1 and continuing for the duration of the trial), contraceptive patch, condoms with spermicide or abstinence.
- If a female of reproductive potential, receive counseling on pregnancy protection and effective contraception within 30 days prior to dosing with secretin.
- Negative serum pregnancy within 72 hours of secretin administration.
Key exclusion criteria (16 listed)
- Male or female <18 or >70 years of age.
- Abnormal serum amylase and/or lipase indicative of acute pancreatitis within 30 days of study enrollment.
- Exhibiting signs and/or symptoms of an episode of acute pancreatitis.
- Severe cardiac disease (stable or unstable angina, congestive heart failure, uncontrolled arrhythmias, implantable defibrillator, severe valvular disease, etc).
- Severe pulmonary disease (COPD, severe asthma, interstitial lung disease, etc).
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 |
|---|---|---|
| Human SecretinAlso: ChiRhoStimDose Escalation | Drug | human secretin |
Primary outcome
VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Time frame: Baseline, Days 1, 2, 3, 4, 7, 30.
10 point visual analog scale. 0= no pain. 10= worst possible pain. Days 1, 2, 3 were infusion days that included 5 VAS scores each day.
Opiate Use at Baseline, Days 4 and 30.
Time frame: Baseline, Day 4, Day 30.
Daily opiate use (oral morphine equivalent).
Quality of Life at Baseline, Day 4 and Day 30.
Time frame: Baseline, Day 4, Day 30.
Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes.
2 secondary outcomes
Number of Participants With Serious Adverse Events.
Time frame: 30 Days
VAS Score at Each Administered Dose.
Time frame: Days 1, 2, and 3.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23548879Levenick JM, Andrews CL, Purich ED, Gordon SR, Gardner TB. A phase II trial of human secretin infusion for refractory type B pain in chronic pancreatitis. Pancreas. 2013 May;42(4):596-600. doi: 10.1097/MPA.0b013e318273f3ec.
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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.
Timothy B Gardner, M.D. principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Human Secretin in people with Chronic Pancreatitis, 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 7 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 9 Mar 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 1 Mar 2016). 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?
VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30. (time frame: Baseline, Days 1, 2, 3, 4, 7, 30.). The study lists 3 primary outcomes in all. 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 NCT01265875, 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 9 Mar 2016.