Pain and Chronic Pancreatitis - Clinical End Experimental Studies (CPP)

This study has been completed.
Sponsor:
Collaborator:
Radboud University
Information provided by:
Aalborg Universityhospital
ClinicalTrials.gov Identifier:
NCT00755573
First received: September 18, 2008
Last updated: August 19, 2010
Last verified: July 2009
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical and Experimental Pilot Study of Pregabalin in Patients With Chronic Pancreatitis

Resource links provided by NLM:


Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 64
Study Start Date: October 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pregabalin
Pregabalin 300 mg - 600 mg BID
Drug: Pregabalin
Pregabalin 300 mg - 600 mg BID
Other Name: Lyrica
Placebo Comparator: Placebo
Placebo arm
Drug: placebo
Regime as described for pregabalin
Other Name: Inactive comparator (placebo)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755573

Locations
Denmark
Department of Gastroenterology, Aalborg Hospital
Aalborg, Denmark, 9000
Netherlands
Department of Suregery, Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500
Sponsors and Collaborators
Aalborg Universityhospital
Radboud University
Investigators
Principal Investigator: Asbjørn M Drewes, MD, PhD Dapartment og Gastroenterology, Aalborg Hospital
  More Information

No publications provided by Aalborg Universityhospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Asbjørn Drewes Professor, Department of Gastroenterology, Aalborg Hospital
ClinicalTrials.gov Identifier: NCT00755573     History of Changes
Other Study ID Numbers: A0081172/8967
Study First Received: September 18, 2008
Last Updated: August 19, 2010
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Aalborg Universityhospital:
Pain
Neuropathic pain

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 29, 2014