NCT00065754

Brief Summary

This study examines the mechanisms, including brain imaging of placebo analgesia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2003

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

September 20, 2011

Status Verified

August 1, 2011

Enrollment Period

4.3 years

First QC Date

July 31, 2003

Last Update Submit

September 16, 2011

Conditions

Irritable Bowel Syndrome

Keywords

PlaceboAnalgesiaPainBrain mechanismExpectation

Interventions

placeboDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Irritable Bowel Syndrome
  • English speaking

You may not qualify if:

  • Chronic pain condition other than Irritable Bowel Syndrome
  • Medical condition that would contraindicate use of lidocaine
  • Clinical criteria for fibromyalgia
  • Presence of systemic disease such as diabetes, thyroid, gastrointestinal or liver disease, collagen vascular disease, malignancy, focal or neurological
  • Seropositive HIV
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeAgnosiaPain

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael E Robinson, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2003

First Posted

August 1, 2003

Study Start

September 1, 2003

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

September 20, 2011

Record last verified: 2011-08

Locations

US(1)