Back to resultsTesting Mestinon and Exercise in Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exercise
pyridostigmine
Placibo
Attention Control
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Exercise, Mestinon
Eligibility Criteria
Inclusion Criteria:
- Have Fibromyalgia
Exclusion Criteria:
- Subjects will be excluded if they have a history of rheumatic disease or other disorder that may compromise ability to safely complete study protocol, be pregnant, nursing, or currently involved in unresolved litigation.
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
Outcomes
Primary Outcome Measures
Levels of Growth Hormone Post Exercise
Serum growth hormone at peak V02/treadmill
Secondary Outcome Measures
Improvement of Fibromyalgia Symptoms
Full Information
NCT ID
NCT00535587
First Posted
September 21, 2007
Last Updated
March 23, 2011
Sponsor
Oregon Health and Science University
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT00535587
Brief Title
Testing Mestinon and Exercise in Fibromyalgia
Official Title
Maximizing Exercise Effectiveness in Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
5. Study Description
Brief Summary
The purpose of this trial was to test the combined and independent effects of 6 months of exercise and Mestinon in people with fibromyalgia. Specifically, we wanted to determine if Mestinon helped people with fibromyalgia have an easier time exercising and if their symptoms improved by the end of the trial.
Detailed Description
Earlier, we demonstrated that people with fibromyalgia fail to make adequate growth hormone when they exercise intensively. We also demonstrated that a single dose of Mestinon helped people make normal levels of growth hormone when they exercised in our laboratory. We wanted to know if 6 months of exercise with concurrent Mestinon therapy would make growth hormone (and related markers) normal and improve fibromyalgia symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Exercise, Mestinon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
178 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Type
Drug
Intervention Name(s)
pyridostigmine
Other Intervention Name(s)
Mestinon
Intervention Type
Drug
Intervention Name(s)
Placibo
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Primary Outcome Measure Information:
Title
Levels of Growth Hormone Post Exercise
Description
Serum growth hormone at peak V02/treadmill
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improvement of Fibromyalgia Symptoms
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have Fibromyalgia
Exclusion Criteria:
Subjects will be excluded if they have a history of rheumatic disease or other disorder that may compromise ability to safely complete study protocol, be pregnant, nursing, or currently involved in unresolved litigation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edit Serfozo, MPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kim Dupree Jones, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97219
Country
United States
12. IPD Sharing Statement
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Testing Mestinon and Exercise in Fibromyalgia
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