Imipramine and Pregabalin Combination in Painful Polyneuropathy
Launched by ODENSE UNIVERSITY HOSPITAL · Jan 12, 2010
Trial Information
Current as of May 02, 2025
Unknown status
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age between 20 - 85 years.
- • Characteristic symptoms of polyneuropathy for at least 6 months.
- • Polyneuropathy diagnosis confirmed by typical clinical signs (distal sensory disturbance/lack of distal deep tendon reflexes) and/or electrophysiological tests and/or abnormal quantitative sensory tests.
- • Total pain intensity rating of at least 4 on a 0-10 points numeric rating scale.
- • Pain present at least 4 days a week.
- • For diabetics: diabetes diagnosis for at least 6 months and stable metabolic control for at least 3 months.
- • For other secondary polyneuropathies: stable for at least 6 months.
- • For fertile females: adequate anticonceptive treatment.
- • Written informed consent.
- Exclusion Criteria:
- • Other cause of pain.
- • Contraindications against imipramine.
- • Allergic reactions towards imipramine or pregabalin.
- • Known adverse reactions during imipramine or pregabalin treatment.
- • Pregnancy.
- • Severe systemic disease.
- • Ongoing treatment with antidepressants, antipsychotics, anticonvulsants, opioids, propranolol, kinidine, monoamine oxidase inhibitor.
- • Inability to follow study protocol.
About Odense University Hospital
Odense University Hospital is a leading academic medical center located in Denmark, dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital is committed to enhancing patient outcomes and fostering collaboration among multidisciplinary teams. With a focus on translating scientific discoveries into practical applications, Odense University Hospital leverages its state-of-the-art facilities and expertise to conduct rigorous trials across various medical fields, ensuring adherence to the highest ethical and regulatory standards. Through these efforts, the hospital aims to contribute significantly to the global body of medical knowledge and improve the quality of care for patients both locally and internationally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Aalborg, , Denmark
Odense, , Denmark
århus, , Denmark
Patients applied
Trial Officials
Søren H. Sindrup, MD
Study Chair
Department of Neurology, Odense University Hospital
Jakob V. Holbech, MD
Principal Investigator
Department of Neurology, Odense University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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