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
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