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Pain and Chronic Pancreatitis - Clinical End Experimental Studies (CPP)
This study is not yet open for participant recruitment.
Verified by Aalborg Hospital, October 2008
Sponsors and Collaborators: Aalborg Hospital
Aarhus University Hospital
Information provided by: Aalborg Hospital
ClinicalTrials.gov Identifier: NCT00755573
  Purpose

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.


Condition Intervention Phase
Chronic Pancreatitis
Drug: Pregabalin
Drug: placebo
Phase II
Phase III

Drug Information available for: Pregabalin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical and Experimental Pilot Study of Pregabalin in Patients With Chronic Pancreatitis

Further study details as provided by Aalborg Hospital:

Primary Outcome Measures:
  • Patient pain diary based on the VAS score [ Time Frame: treatmentday -7 to +21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Questionaries addressing quality of life and daily performance status: PDQ, PGIC, QOLQ and mBPIsf [ Time Frame: before and after study treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Pregabalin 300 mg - 600 mg BID
Drug: Pregabalin
Pregabalin 300 mg - 600 mg BID
2: Placebo Comparator
Placebo arm
Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755573

Contacts
Contact: Søren Schou Olesen, MD +45 99321100 soren.s.olesen@gmail.com
Contact: Asbjørn Mohr Drewes, Profssor, MD +45 99321100 drewes@hst.aau.dk

Locations
Denmark
Department of Gastroenterology, Aalborg Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Aalborg Hospital
Aarhus University Hospital
Investigators
Principal Investigator: Asbjørn Mohr Drewes, Professor, MD Dapartment og Gastroenterology, Aalborg Hospital
  More Information

Responsible Party: Department of Gastroenterology, Aalborg Hospital ( Asbjørn Drewes Professor )
Study ID Numbers: A0081172/8967
Study First Received: September 18, 2008
Last Updated: October 10, 2008
ClinicalTrials.gov Identifier: NCT00755573  
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Aalborg Hospital:
Pain
Neuropathic pain

Study placed in the following topic categories:
Digestive System Diseases
Pregabalin
Pancreatic Diseases
Pain
Pancreatitis
Pancreatitis, Chronic

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009