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Pain and Chronic Pancreatitis - Clinical End Experimental Studies

Information source: Aalborg Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Pancreatitis

Intervention: Pregabalin (Drug); placebo (Drug)

Phase: Phase 2/Phase 3

Status: Not yet recruiting

Sponsored by: Aalborg Hospital

Official(s) and/or principal investigator(s):
Asbjørn Mohr Drewes, Professor, MD, Principal Investigator, Affiliation: Dapartment og Gastroenterology, Aalborg Hospital

Overall contact:
Søren Schou Olesen, MD, Phone: +45 99321100, Email: soren.s.olesen@gmail.com

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 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.

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical and Experimental Pilot Study of Pregabalin in Patients With Chronic Pancreatitis

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Primary outcome: Patient pain diary based on the VAS score

Secondary outcome: Questionaries addressing quality of life and daily performance status: PDQ, PGIC, QOLQ and mBPIsf

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Male or female patients between the ages of 18 and 70 years with a diagnosis of chronic pancreatitis, diagnosed using the Marseille-Rome/Cambridge diagnostic criteria. 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 or Transdermal Plaster

9. Patients unwilling or unable to comply with the lifestyle guidelines.

10. Patients must not suffer from painful conditions other than chronic pancreatitis.

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.

Locations and Contacts

Søren Schou Olesen, MD, Phone: +45 99321100, Email: soren.s.olesen@gmail.com

Department of Gastroenterology, Aalborg Hospital, Aalborg 9000, Denmark
Additional Information

Starting date: October 2008
Ending date: March 2010
Last updated: October 10, 2008

Page last updated: November 03, 2008

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