Trial Outcomes & Findings for Testing Mestinon and Exercise in Fibromyalgia (NCT NCT00535587)
NCT ID: NCT00535587
Last Updated: 2011-04-18
Results Overview
Serum growth hormone at peak V02/treadmill
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
178 participants
Primary outcome timeframe
6 months
Results posted on
2011-04-18
Participant Flow
Participant milestones
| Measure |
Mestinon & Exercise
|
Mestinon and Attention Control
|
Placebo Pill and Exercise
|
Placebo Pill and Attention Control
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
53
|
53
|
47
|
54
|
|
Overall Study
COMPLETED
|
43
|
42
|
39
|
41
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
8
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing Mestinon and Exercise in Fibromyalgia
Baseline characteristics by cohort
| Measure |
Mestinon & Exercise
n=53 Participants
|
Mestinon and Attention Control
n=53 Participants
|
Placebo Pill and Exercise
n=47 Participants
|
Placebo Pill and Attention Control
n=54 Participants
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
207 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age Continuous
|
49 years
STANDARD_DEVIATION 9 • n=99 Participants
|
49 years
STANDARD_DEVIATION 8 • n=107 Participants
|
50 years
STANDARD_DEVIATION 7 • n=206 Participants
|
49 years
STANDARD_DEVIATION 8 • n=7 Participants
|
49 years
STANDARD_DEVIATION 8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
201 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=99 Participants
|
53 participants
n=107 Participants
|
47 participants
n=206 Participants
|
54 participants
n=7 Participants
|
207 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: ITT
Serum growth hormone at peak V02/treadmill
Outcome measures
| Measure |
Mestinon/Exercise
n=43 Participants
|
Placebo Pill/Attention Control
n=41 Participants
|
|---|---|---|
|
Levels of Growth Hormone Post Exercise
|
4.95 ng/ml
Standard Deviation 3.07
|
1.41 ng/ml
Standard Deviation 2.94
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
Adverse Events
Mestinon & Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mestinon and Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Pill and Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Pill and Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place