Chronic PancreatitisPhase 2NCT00469703
Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis
A Phase 2 study testing Thalidomide in people with Chronic Pancreatitis, run by Winthrop University Hospital.
Trial summary
The purpose of this study is to determine if Thalidomide (Thalomid) is effective in treating patients with chronic pancreatitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Thalidomide
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Nov 2007
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75, inclusive.
- Female must be post menopausal (≥ 24 months without menses or surgically sterilized).
- Able to comprehend English.
- Chronic pancreatic pain lasting for more than 2 months.
- History of chronic pancreatitis with pancreatic type pain confirmed by at least one of the following:
- Histological confirmation
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- CT/MRI (including calcifications, dilated cuts, dilated MPD, and /or atrophy)
- ERCP with Cambridge score of 2 or greater
- Subject must score at least 4 cm on the VAS scale during the 1-2 week lead-in-period.
- Patients must give written informed consent.
- Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program.
Who cannot join
- Female of child-bearing potential.
- Unable to comprehend English.
- Patients with diabetes requiring insulin.
- Evidence of gallstones on screening ultrasonography.
- Current alcohol abuse or addiction to opiate analgesics.
- Patients with existing peripheral neuropathy.
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- Patients who are taking medications known to be associated with development of neuropathy: Amiodarone, hydralazine, perhexiline, vincristine, cisplatin, Metronidazole (Flagyl), Dapsone, Phenytoin and Disulfiram.
- Patients who have pre-existing hypercoagulable state. Patients with a history of malignancy within the past 5 years, patients with a recent surgical procedure, patients with chronic immobilization causing blood stasis, patients with history of embolism or deep vein thrombosis, patients with extreme heart failure, and patients with a congenital disorder of the clotting cascade.
- Patients with active alcoholic liver disease or elevated liver function >3Xs the upper limit of normal.
- Patients will be withdrawn from the study at Visit 4 (Month 3) if pain score on VAS scale has not improved.
About this study
Official title: A Phase II, Open-Label, Single Center Pilot Study to Determine the Safety and Efficacy of THALOMID (Thalidomide) in Patients With Chronic Pancreatitis.
The purpose of this study is to determine if Thalidomide (Thalomid) is effective in treating patients with chronic pancreatitis.
Read the detailed description
Pancreatitis is an inflammation of the pancreas, a gland that lies behind the stomach. The inflammation may develop suddenly (acute pancreatitis) or over many years (chronic pancreatitis). The pancreas produces the hormones, insulin and glucagon to control metabolism. The hormones and enzymes flow from the pancreas through the pancreatic duct into the upper part of the small intestine.
Most chronic pancreatitis patients often experience chronic abdominal pain during the course of the disease. Thalidomide increased the production of interleukin-10 (IL-10), which is important in regulating intestinal inflammation. Thalidomide is approved by the Food and Drug Administration (FDA) for a leprosy skin condition, erythema nodosum lerosum (ENL), but not for the treatment of chronic pancreatitis. In this case it is considered experimental.
- Conditions
- Chronic Pancreatitis
- Being tested
- Thalidomide
- Keywords
- Pancreatitis
- Medical subject headings
- Pancreatitis, Chronic, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy
Secondary outcomes (3)
reduction of frequency of hospitalizations
quality of life
reduction of pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startAug 2005
- Primary completionNov 2007
- Study completionNov 2007
Why it stopped: Terminated
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Investigators
- James H Grendell, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469703
- Sponsor's protocol ID
- Chronic Pancreatitis
- Status last verified
- Jan 2008
- First submitted
- 3 May 2007
- Last updated
- 16 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Single Center Pilot Study to Determine the Safety and Efficacy of THALOMID (Thalidomide) in Patients With Chronic Pancreatitis.
- ClinicalTrials.gov ID
- NCT00469703
- Acronym / sponsor ID
- Chronic Pancreatitis
- Conditions
- Chronic Pancreatitis
- Keywords
- Pancreatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Aug 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 4 May 2007 (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.
The purpose of this study is to determine if Thalidomide (Thalomid) is effective in treating patients with chronic pancreatitis.
Detailed description
Pancreatitis is an inflammation of the pancreas, a gland that lies behind the stomach. The inflammation may develop suddenly (acute pancreatitis) or over many years (chronic pancreatitis). The pancreas produces the hormones, insulin and glucagon to control metabolism. The hormones and enzymes flow from the pancreas through the pancreatic duct into the upper part of the small intestine.
Most chronic pancreatitis patients often experience chronic abdominal pain during the course of the disease. Thalidomide increased the production of interleukin-10 (IL-10), which is important in regulating intestinal inflammation. Thalidomide is approved by the Food and Drug Administration (FDA) for a leprosy skin condition, erythema nodosum lerosum (ENL), but not for the treatment of chronic pancreatitis. In this case it is considered experimental.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-75, inclusive.
- Female must be post menopausal (≥ 24 months without menses or surgically sterilized).
- Able to comprehend English.
- Chronic pancreatic pain lasting for more than 2 months.
- History of chronic pancreatitis with pancreatic type pain confirmed by at least one of the following:
Key exclusion criteria (10 listed)
- Female of child-bearing potential.
- Unable to comprehend English.
- Patients with diabetes requiring insulin.
- Evidence of gallstones on screening ultrasonography.
- Current alcohol abuse or addiction to opiate analgesics.
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 |
|---|---|---|
| Thalidomide | Drug | – |
Primary outcome
Safety and efficacy
3 secondary outcomes
reduction of frequency of hospitalizations
quality of life
reduction of pain
Results and safety
The study was stopped early (reason given: Terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2008.
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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.
James H Grendell, MD principal investigator
Winthrop University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide in people with Chronic Pancreatitis, run by Winthrop University Hospital.
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 11 inclusion and 10 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: stopped early, as of the sponsor's last update on 16 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Terminated). Results are not available in the source record.
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?
Safety and efficacy. 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 16 Jan 2008.