NCT00889499

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_2 pain

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

March 24, 2011

Status Verified

March 1, 2011

Enrollment Period

1.1 years

First QC Date

April 28, 2009

Last Update Submit

March 23, 2011

Conditions

PainChronic Disease

Outcome Measures

Primary Outcomes (1)

  • Pain intensity (VAS score)

    2 h

Secondary Outcomes (1)

  • Measures of central hypersensitivity

    2 h

Study Arms (3)

Crossover study

PLACEBO COMPARATOR

Crossover study

Drug: Tropisetron 2 mg

2

PLACEBO COMPARATOR

Crossover Study

Drug: Tropisetron 5mg

3

PLACEBO COMPARATOR

Crossover Study

Drug: Placebo

Interventions

Tropisetron 2 mgDRUG

Antagonist of the 5HT3 receptor.

Crossover study
Tropisetron 5mgDRUG

Antagonist of the 5HT3 receptor.

2
PlaceboDRUG

NHCL 0,9%

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic musculoskeletal pain
  • Pain duration at least 6 months

You may not qualify if:

  • Pregnancy
  • Breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Anesthesiology and Pain Therapy, Bern University Hospital, Inselspital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

PainChronic Disease

Interventions

Tropisetron

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Michele Curatolo, Prof

    Inselspital, Bern University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 28, 2009

First Posted

April 29, 2009

Study Start

March 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

March 24, 2011

Record last verified: 2011-03

Locations

CH(1)