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Modulation of Central Hypersensitivity in Chronic Musculoskeletal Pain by Intravenous Tropisetron

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00889499
First received: April 28, 2009
Last updated: March 23, 2011
Last verified: March 2011
History of Changes
  Purpose

Chronic pain is associated with hypersensitivity of the central nervous system. The drug under investigation (tropisetron) has been shown in animal studies to attenuate central hypersensitivity. It has therefore the potential to be effective in chronic pain. We compare two doses of tropisetron with placebo in patients with chronic pain. We measure pain intensity and parameters that assess central hypersensitivity.


Condition Intervention Phase
Pain
Chronic Disease
 Drug: Tropisetron 2 mg
Drug: Tropisetron 5mg
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modulation of Central Hypersensitivity in Chronic Musculoskeletal Pain by Intravenous Tropisetron

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Pain intensity (VAS score) [ Time Frame: 2 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measures of central hypersensitivity [ Time Frame: 2 h ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: March 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Crossover study
Crossover study
 Drug: Tropisetron 2 mg
Antagonist of the 5HT3 receptor.
Placebo Comparator: 2
Crossover Study
 Drug: Tropisetron 5mg
Antagonist of the 5HT3 receptor.
Placebo Comparator: 3
Crossover Study
 Drug: Placebo
NHCL 0,9%

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic musculoskeletal pain
  • Pain duration at least 6 months

Exclusion Criteria:

  • Pregnancy
  • Breast feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889499

Locations
Switzerland
Dep. of Anesthesiology and Pain Therapy, Bern University Hospital, Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Study Director: Michele Curatolo, Prof Inselspital, Bern University Hospital
  More Information

No publications provided

Responsible Party: Michele Curatolo / Prof., Inselspital, Bern University Hospital, Switzerland
ClinicalTrials.gov Identifier: NCT00889499     History of Changes
Other Study ID Numbers: KEK 146/04
Study First Received: April 28, 2009
Last Updated: March 23, 2011
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Additional relevant MeSH terms:
Chronic Disease
Hypersensitivity
Disease Attributes
Pathologic Processes
Immune System Diseases
Tropisetron
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2013