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Modulation of Central Hypersensitivity in Chronic Musculoskeletal Pain by Intravenous Tropisetron

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ClinicalTrials.gov Identifier: NCT00889499
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : March 24, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pain Chronic Disease Drug: Tropisetron 2 mg Drug: Tropisetron 5mg Drug: Placebo Phase 2

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modulation of Central Hypersensitivity in Chronic Musculoskeletal Pain by Intravenous Tropisetron
Study Start Date : March 2009
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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%


Outcome Measures

Primary Outcome Measures :
  1. Pain intensity (VAS score) [ Time Frame: 2 h ]

Secondary Outcome Measures :
  1. Measures of central hypersensitivity [ Time Frame: 2 h ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic musculoskeletal pain
  • Pain duration at least 6 months

Exclusion Criteria:

  • Pregnancy
  • Breast feeding
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Michele Curatolo / Prof., Inselspital, Bern University Hospital, Switzerland
ClinicalTrials.gov Identifier: NCT00889499     History of Changes
Other Study ID Numbers: KEK 146/04
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: March 24, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Hypersensitivity
Chronic Disease
Musculoskeletal Pain
Immune System Diseases
Disease Attributes
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Tropisetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action