Status:
COMPLETED
Pain and Chronic Pancreatitis - Clinical End Experimental Studies
Lead Sponsor:
Aalborg University Hospital
Collaborating Sponsors:
Radboud University Medical Center
Conditions:
Chronic Pancreatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of the study is to investigate the effect of pregabalin in pain resulting from chronic pancreatitis. The effect will be investigated by means of questionnaires concerning the daily experience ...
Detailed Description
Background and Rationale The aetiology of pain in chronic pancreatitis remains to be elucidated. Therefore no common guidelines for the management of the pain exist and it is a topic of great discuss...
Eligibility Criteria
Inclusion
- Male or female patients between the ages of 18 and 75 years with a diagnosis of chronic pancreatitis diagnosed using the Mayo Clinic Diagnostic criteria criteria ((Layer P, Gastroenterology 1994;107:1481-1487\]). Both diabetic and non-diabetic patients will be allowed to enter the study.
- The patients must suffer from chronic abdominal pain typical for pancreatitis, meet the criteria for chronic pain (pain ≥ 3 days per week in at least 3 months) and must consider their pain as severe enough for medical treatment.
- Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
- Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
Exclusion
- Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator
- Presence or history of major depression
- Patients with previously diagnosed moderate to severe renal impairment. Patients with creatinine values \> 2x ULN and/or with a significant change to their normal values should be excluded.
- Patients with a screening 12-lead ECG demonstrating any of the following: heart rate \>100 bpm, QRS duration \>120 msec, QTc interval \>450 msec, PR interval \>210 msec, any clinically significant rhythm abnormality, any evidence of myocardial ischemia or injury.
- Patients with any clinically significant laboratory abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
- Patients treated with pregabalin (Lyrica®) during the previous 4 months.
- Treatment with an investigational drug within 4 months preceding the first dose of study medication of importance for this study as judged by investigator.
- Female patients who are pregnant or lactating, or intend to become pregnant. Male patients who intend to father a child during the course of the study. A pregnancy test will be conducted at visit 1 and 3 to ensure that female patients are not pregnant during the study period. The investigator will have to ensure that fertile female patients use a safe contraception method during the study and for at least 35 hours after termination of the study period. The following methods are considered as safe contraception methods:
- The pill
- IUD
- Gestagen Injection
- Subdermal Implantation (Implanon)
- Hormone vaginal ring
- Transdermal Plaster
- Patients unwilling or unable to comply with the lifestyle guidelines.
- Patients must not suffer from generalized painful conditions other than chronic pancreatitis; however patients with localized painful disorders will be allowed to enter the study
- Clinical significant illness within two weeks of participating in this study.
- Involved in planning or conducting the study.
- Hypersensitivity to pregabalin or any of its components.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00755573
Start Date
October 1 2008
End Date
May 1 2010
Last Update
August 20 2010
Active Locations (2)
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1
Department of Gastroenterology, Aalborg Hospital
Aalborg, Denmark, 9000
2
Department of Suregery, Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500