Chronic Pancreatitis Clinical Trial
— CPPOfficial title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical and Experimental Pilot Study of Pregabalin in Patients With Chronic Pancreatitis
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 of pain and the general quality of life. Furthermore the patients will be invited to participate in experimental testing with a multimodal pain model. The experimental testing will include stimulation of the skin, muscle and visceral tissue. The results from the experimental part of the study may help us to understand the mechanisms of action of pregabalin in this patient population.
Status | Completed |
Enrollment | 64 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. 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. 2. 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. 3. Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial. 4. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures. Exclusion Criteria: 1. Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator 2. Presence or history of major depression 3. 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. 4. 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. 5. 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. 6. Patients treated with pregabalin (Lyrica®) during the previous 4 months. 7. Treatment with an investigational drug within 4 months preceding the first dose of study medication of importance for this study as judged by investigator. 8. 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 9. Patients unwilling or unable to comply with the lifestyle guidelines. 10. 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 11. Clinical significant illness within two weeks of participating in this study. 12. Involved in planning or conducting the study. 13. Hypersensitivity to pregabalin or any of its components. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Gastroenterology, Aalborg Hospital | Aalborg | |
Netherlands | Department of Suregery, Radboud University Nijmegen Medical Centre | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Aalborg Universitetshospital | Radboud University |
Denmark, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient pain diary based on the VAS score and different questionaries | The primary efficacy parameter to be evaluated is pain relief assessed using a patient pain diary based on the visual analog scale (VAS). Furthermore different questionnaires, including the modified brief pain inventory-short form (mBPI-sf), the painDETECT questionnaire (PD-Q) and patient global impression of change (PGIC)will be used to explore further aspects of pain character and influence on cognitive and affective components. | Pain diary treatmentday -7 to +21. Questionaries are adressed 7 days prior to study medication and on day 21 during the study medication period | No |
Secondary | Questionary addressing quality of life | Secondary efficacy parameters are changes in quality of life compared to baseline level. The European Organization for research and treatment of cancer quality of life questionnaire (EORTC QOL-C30).Also the tolerability of the drug in this patient population will be compared to placebo. | Questionaries are adressed 7 days prior to study medication and on day 21 during the study medication period | Yes |
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