Trial Outcomes & Findings for Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction) (NCT NCT00471315)
NCT ID: NCT00471315
Last Updated: 2014-02-06
Results Overview
The primary outcome measure was a Patient Global Assessment of Change (PGIC) scale which reports the patient's overall view of any changes in their overall status since their sphincterotomy treatment. (1=Very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). Success was defined as 3-month PGIC score of much or very much improved (PGIC of either 1 or 2). Patients missing the 3 month visit were considered failures for the primary outcome.
COMPLETED
PHASE3
18 participants
3 months
2014-02-06
Participant Flow
Participant milestones
| Measure |
Duloxetine
Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Duloxetine
Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction)
Baseline characteristics by cohort
| Measure |
Duloxetine
n=18 Participants
Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
|
|---|---|
|
Age, Continuous
|
43.7 years
STANDARD_DEVIATION 10.3 • n=39 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe primary outcome measure was a Patient Global Assessment of Change (PGIC) scale which reports the patient's overall view of any changes in their overall status since their sphincterotomy treatment. (1=Very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). Success was defined as 3-month PGIC score of much or very much improved (PGIC of either 1 or 2). Patients missing the 3 month visit were considered failures for the primary outcome.
Outcome measures
| Measure |
Duloxetine
n=18 Participants
Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
|
|---|---|
|
The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale.
|
3.3 units on a scale
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: 3 MonthsThe secondary outcome measure of the study was number of patients who remained on Duloxetine at the completion of the study.
Outcome measures
| Measure |
Duloxetine
n=18 Participants
Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
|
|---|---|
|
Toleration of the Medication as Measured by the Duloxetine Compliance Rate
|
10 participants
|
Adverse Events
Duloxetine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Duloxetine
n=18 participants at risk
Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
|
|---|---|
|
General disorders
Fatigue
|
61.1%
11/18 • Number of events 11
|
|
General disorders
Nausea
|
55.6%
10/18 • Number of events 10
|
|
General disorders
Headaches
|
27.8%
5/18 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
22.2%
4/18 • Number of events 4
|
|
Gastrointestinal disorders
Decreased appetite
|
22.2%
4/18 • Number of events 4
|
|
General disorders
Insomnia
|
22.2%
4/18 • Number of events 4
|
Additional Information
Peter Cotton, MD
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place