PancreatitisNCT00534534
Decrease of Recurrent Pancreatitis
A study testing Repeated behavioural intervention without any drugs in people with Pancreatitis, run by Tampere University at 1 site in Finland.
Trial summary
Retrospective studies have shown, that about half of the patients will have a recurrent episode after the first acute alcoholic pancreatitis. Of the patients in hospital, more than half annually are treated for recurrent acute pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- What is being tested?
- Repeated behavioural intervention without any drugs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2001to Apr 2007
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who recovered from their first acute alcoholic pancreatitis and start to be ready to be discharged from hospital
Who cannot join
- Other etiologies of pancreatitis besides alcohol
- Uncertain diagnosis
- Recurrent disease
- Refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial of the Effect of Standard Versus Intensive Intervention Protocol in Attempting to Reduce Recurrent Episodes of Acute Alcoholic Pancreatitis
Retrospective studies have shown, that about half of the patients will have a recurrent episode after the first acute alcoholic pancreatitis. Of the patients in hospital, more than half annually are treated for recurrent acute pancreatitis. Because alcohol has been shown an important factor in the development of recurrent pancreatitis, it was hypothesized, that by attempting intensively to diminish the individual alcohol consumption the number of recurrent pancreatitis could be decreased. Two protocols will be compared: A) initial intervention against alcohol abuse and B) repeated interventions at 6 month intervals.
- Conditions
- Pancreatitis
- Being tested
- Repeated behavioural intervention without any drugs
- Keywords
- Pancreatitis, acute, alcoholic, recurrence, alcoholism, treatment, Acute alcoholic pancreatitis
- Medical subject headings
- Pancreatitis, Recurrence, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated behavioural intervention without any drugsBehavioural
All these patients will be advised, i.e. undergo "behavioural intervention", against alcohol use in the standard fashion as those in the standard group. No drugs will be used as part of the intervention. They also will undergo repeated interventions at outpatient visits at 6 mo intervals. They are re-examined at two years for alcohol consumption and for the number of recurrent pancreatitis during the two year period.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | All these patients will be advised, i.e. undergo behavioural intervention, against alcohol use in the standard fashion. No drugs will be used. In addition, they also will undergo repeated similar interventions at 6 mo intervals. They are re-examined at two years for alcohol consumption and for the number of recurrent pancreatitis during the two year period. Receives: Behavioral: Repeated behavioural intervention without any drugs |
| Standard | No intervention | All these patients will be advised, i.e. undergo behavioural intervention, against alcohol use in the standard fashion. No drugs will be used. They are re-examined at two years for alcohol consumption and for the number of recurrent pancreatitis during the two year period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of recurrent pancreatitis during the study period
Measured: 2 years
Secondary outcomes (1)
Decrease of alcohol consumption
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startJan 2001
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Investigators
- Isto H Nordback, M.D., Study chair, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534534
- Sponsor's protocol ID
- R00126A
- Status last verified
- Sep 2007
- First submitted
- 21 Sep 2007
- Last updated
- 26 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of the Effect of Standard Versus Intensive Intervention Protocol in Attempting to Reduce Recurrent Episodes of Acute Alcoholic Pancreatitis
- ClinicalTrials.gov ID
- NCT00534534
- Acronym / sponsor ID
- R00126A
- Conditions
- Pancreatitis
- Keywords
- Pancreatitis, acute, alcoholic, recurrence, alcoholism, treatment, Acute alcoholic pancreatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Study start
- Jan 2001
- Study completion
- Apr 2007 (actual)
- First posted
- 26 Sep 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.
Retrospective studies have shown, that about half of the patients will have a recurrent episode after the first acute alcoholic pancreatitis. Of the patients in hospital, more than half annually are treated for recurrent acute pancreatitis. Because alcohol has been shown an important factor in the development of recurrent pancreatitis, it was hypothesized, that by attempting intensively to diminish the individual alcohol consumption the number of recurrent pancreatitis could be decreased. Two protocols will be compared: A) initial intervention against alcohol abuse and B) repeated interventions at 6 month intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Repeated behavioural intervention without any drugsAll these patients will be advised, i.e. undergo behavioural intervention, against alcohol use in the standard fashion. No drugs will be used. In addition, they also will undergo repeated similar interventions at 6 mo intervals. They are re-examined at two years for alcohol consumption and for the number of recurrent pancreatitis during the two year period. |
| Standard | No intervention | –All these patients will be advised, i.e. undergo behavioural intervention, against alcohol use in the standard fashion. No drugs will be used. They are re-examined at two years for alcohol consumption and for the number of recurrent pancreatitis during the two year period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who recovered from their first acute alcoholic pancreatitis and start to be ready to be discharged from hospital
Key exclusion criteria (4 listed)
- Other etiologies of pancreatitis besides alcohol
- Uncertain diagnosis
- Recurrent disease
- Refusal
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 |
|---|---|---|
| Repeated behavioural intervention without any drugsAll these patients will be advised, i.e. undergo "behavioural intervention", against alcohol use in the standard fashion as those in the standard group. No drugs will be used as part of the intervention. They also will undergo repeated interventions at outpatient visits at 6 mo intervals. They are re-examined at two years for alcohol consumption and for the number of recurrent pancreatitis during the two year period. | Behavioural | 1 |
Primary outcome
The number of recurrent pancreatitis during the study period
Time frame: 2 years
1 secondary outcome
Decrease of alcohol consumption
Time frame: 2 years
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 26 Sep 2007.
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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.
Isto H Nordback, M.D. study chair
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated behavioural intervention without any drugs in people with Pancreatitis, run by Tampere University at 1 site in Finland.
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 1 inclusion and 4 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 26 Sep 2007. 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 Finland. 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.
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?
The number of recurrent pancreatitis during the study period (time frame: 2 years). 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 26 Sep 2007.