Pain and Chronic Pancreatitis - Clinical End Experimental Studies

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00755573
• Date of registration: 18/09/2008
• Prospective Registration: Yes
• Primary sponsor: Aalborg Universitetshospital
• Public title: Pain and Chronic Pancreatitis - Clinical End Experimental Studies CPP
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical and Experimental Pilot Study of Pregabalin in Patients With Chronic Pancreatitis
• Date of first enrolment: October 2008
• Target sample size: 64
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00755573
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Denmark, Netherlands

Contacts

• Name: Asbjørn M Drewes, MD, PhD
• Affiliation: Dapartment og Gastroenterology, Aalborg Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Pancreatitis

Intervention(s)

Drug: placebo

Drug: Pregabalin

Primary Outcome(s)

Patient pain diary based on the VAS score and different questionaries [Time Frame: Pain diary treatmentday -7 to +21. Questionaries are adressed 7 days prior to study medication and on day 21 during the study medication period]

Secondary Outcome(s)

Questionary addressing quality of life [Time Frame: Questionaries are adressed 7 days prior to study medication and on day 21 during the study medication period]

Secondary ID(s)

A0081172/8967

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Radboud University