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Sponsors and Collaborators: |
Aalborg Hospital Aarhus University Hospital |
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Information provided by: | Aalborg Hospital |
ClinicalTrials.gov Identifier: | NCT00755573 |
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 |
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Chronic Pancreatitis |
Drug: Pregabalin Drug: placebo |
Phase II Phase III |
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 |
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 |
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1: Active Comparator
Pregabalin 300 mg - 600 mg BID
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Drug: Pregabalin
Pregabalin 300 mg - 600 mg BID
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2: Placebo Comparator
Placebo arm
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Drug: placebo |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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
Contact: Søren Schou Olesen, MD | +45 99321100 | soren.s.olesen@gmail.com |
Contact: Asbjørn Mohr Drewes, Profssor, MD | +45 99321100 | drewes@hst.aau.dk |
Denmark | |
Department of Gastroenterology, Aalborg Hospital | |
Aalborg, Denmark, 9000 |
Principal Investigator: | Asbjørn Mohr Drewes, Professor, MD | Dapartment og Gastroenterology, Aalborg Hospital |
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 |
Pain Neuropathic pain |
Digestive System Diseases Pregabalin Pancreatic Diseases |
Pain Pancreatitis Pancreatitis, Chronic |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Peripheral Nervous System Agents |
Analgesics Central Nervous System Agents Anticonvulsants Pharmacologic Actions |