Trial Outcomes & Findings for Research Examining Gulf War Illness in Our Nations Service Members (NCT NCT01846182)
NCT ID: NCT01846182
Last Updated: 2021-03-12
Results Overview
Likert scale of pain rating
TERMINATED
PHASE2
112 participants
120 days
2021-03-12
Participant Flow
Patient recruitment was very difficult.
Participant milestones
| Measure |
Group 1
60 mg of duloxetine in the AM for 20 weeks
Duloxetine: serotonin norepinephrine reuptake inhibitor
Placebo: Placebo
|
Group 2
300 mg of pregabalin in the PM for 20 weeks
Pregabalin: alpha-2-alpha subunit calcium channel ligand
Placebo: Placebo
|
Group 3
placebo in the AM \& PM for 20 weeks
Placebo: Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Research Examining Gulf War Illness in Our Nations Service Members
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 120 daysPopulation: Data collection was inaccurate and data are considered unreliable for evaluation.
Likert scale of pain rating
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed every 2 weeksPopulation: Data collection was inaccurate and data are considered unreliable for evaluation.
Side effects checklist
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed every 2 weeks up to 34 weeksPopulation: Data were inaccurately collected and are considered unreliable for interpretation.
Reliability of measurement is highly suspect and data are not suitable for analysis.
Outcome measures
Outcome data not reported
Adverse Events
Group 1
Group 2
Group 3
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Charles J. Foulks, M.D., ACOS/R
Central Texas Veterans Health Care System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place