Trial Outcomes & Findings for Secretin Infusion for Pain Due to Chronic Pancreatitis (NCT NCT01265875)
NCT ID: NCT01265875
Last Updated: 2016-03-09
Results Overview
10 point visual analog scale. 0= no pain. 10= worst possible pain. Days 1, 2, 3 were infusion days that included 5 VAS scores each day.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Baseline, Days 1, 2, 3, 4, 7, 30.
Results posted on
2016-03-09
Participant Flow
Participant milestones
| Measure |
Human Secretin
Human Secretin : Dose Escalation
There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits.
|
|---|---|
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Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Human Secretin
Human Secretin : Dose Escalation
There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits.
|
|---|---|
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Overall Study
Uncooperative/unreliable
|
1
|
Baseline Characteristics
Secretin Infusion for Pain Due to Chronic Pancreatitis
Baseline characteristics by cohort
| Measure |
Human Secretin
n=12 Participants
Human Secretin : Dose Escalation
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Days 1, 2, 3, 4, 7, 30.10 point visual analog scale. 0= no pain. 10= worst possible pain. Days 1, 2, 3 were infusion days that included 5 VAS scores each day.
Outcome measures
| Measure |
Human Secretin
n=12 Participants
Human Secretin : Dose Escalation
|
|---|---|
|
VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Baseline
|
5.71 units on a scale
Standard Deviation 1.45
|
|
VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 1 Pre-dose
|
6.04 units on a scale
Standard Deviation 2.13
|
|
VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 1 Dose 1 (.05mcg/kg) 100min post dose
|
4.92 units on a scale
Standard Deviation 2.20
|
|
VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 1 Dose 2 (.1mcg/kg) 100 min post dose
|
4.87 units on a scale
Standard Deviation 2.06
|
|
VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 1 Dose 3 (.2mcg/kg) 100 min post dose
|
5.30 units on a scale
Standard Deviation 2.19
|
|
VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 1 Dose 3 (.2mcg/kg) 380 min post dose
|
4.64 units on a scale
Standard Deviation 2.68
|
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VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 2 Pre-dose
|
5.33 units on a scale
Standard Deviation 2.30
|
|
VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 2 Dose 1 (.1mcg/kg) 100min post dose
|
5.25 units on a scale
Standard Deviation 1.88
|
|
VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 2 Dose 2 (.2mcg/kg) 100min post dose
|
5.50 units on a scale
Standard Deviation 1.71
|
|
VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 2 Dose 3 (.4mcg/kg) 100min post dose
|
4.67 units on a scale
Standard Deviation 2.32
|
|
VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 2 Dose 3 (.4mcg/kg) 380min post dose
|
4.77 units on a scale
Standard Deviation 2.60
|
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VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 3 Pre-dose
|
4.92 units on a scale
Standard Deviation 2.36
|
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VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 3 Dose 1 (.2mcg/kg) 100min post dose
|
4.58 units on a scale
Standard Deviation 2.15
|
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VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 3 Dose 2 (.4mcg/kg) 100min post dose
|
4.33 units on a scale
Standard Deviation 2.11
|
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VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 3 Dose 3 (.8mcg/kg) 100min post dose
|
5.17 units on a scale
Standard Deviation 2.44
|
|
VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 3 Dose 3 (.8mcg/kg) 380min post dose
|
4.71 units on a scale
Standard Deviation 2.47
|
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VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 4
|
4.80 units on a scale
Standard Deviation 2.49
|
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VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 7
|
5.18 units on a scale
Standard Deviation 2.62
|
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VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
Day 30
|
4.91 units on a scale
Standard Deviation 2.20
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PRIMARY outcome
Timeframe: Baseline, Day 4, Day 30.Daily opiate use (oral morphine equivalent).
Outcome measures
| Measure |
Human Secretin
n=12 Participants
Human Secretin : Dose Escalation
|
|---|---|
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Opiate Use at Baseline, Days 4 and 30.
Baseline
|
139.6 mg/day
Standard Deviation 90.5
|
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Opiate Use at Baseline, Days 4 and 30.
Day 4
|
127.0 mg/day
Standard Deviation 99.2
|
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Opiate Use at Baseline, Days 4 and 30.
Day 30
|
97.2 mg/day
Standard Deviation 80.5
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PRIMARY outcome
Timeframe: Baseline, Day 4, Day 30.Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes.
Outcome measures
| Measure |
Human Secretin
n=12 Participants
Human Secretin : Dose Escalation
|
|---|---|
|
Quality of Life at Baseline, Day 4 and Day 30.
Baseline
|
100.92 units on a scale
Standard Deviation 5.26
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Quality of Life at Baseline, Day 4 and Day 30.
Day 4
|
100.9 units on a scale
Standard Deviation 6.42
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Quality of Life at Baseline, Day 4 and Day 30.
Day 30
|
101.45 units on a scale
Standard Deviation 5.68
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SECONDARY outcome
Timeframe: 30 DaysOutcome measures
| Measure |
Human Secretin
n=12 Participants
Human Secretin : Dose Escalation
|
|---|---|
|
Number of Participants With Serious Adverse Events.
|
3 participants
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SECONDARY outcome
Timeframe: Days 1, 2, and 3.10 point scare from 0-10 with higher scores meaning higher levels of pain. VAS score assessed after each dose was summarized over Days 1, 2, and 3.
Outcome measures
| Measure |
Human Secretin
n=12 Participants
Human Secretin : Dose Escalation
|
|---|---|
|
VAS Score at Each Administered Dose.
.8 mcg/kg
|
5.36 units on a scale
Standard Deviation 2.46
|
|
VAS Score at Each Administered Dose.
Pre-dose
|
6.04 units on a scale
Standard Deviation 2.13
|
|
VAS Score at Each Administered Dose.
.05 mcg/kg
|
4.92 units on a scale
Standard Deviation 2.2
|
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VAS Score at Each Administered Dose.
.1 mcg/kg
|
5.06 units on a scale
Standard Deviation 1.94
|
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VAS Score at Each Administered Dose.
.2 mcg/kg
|
4.92 units on a scale
Standard Deviation 2.14
|
|
VAS Score at Each Administered Dose.
.4 mcg/kg
|
4.5 units on a scale
Standard Deviation 2.18
|
Adverse Events
Human Secretin
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Human Secretin
n=12 participants at risk
Human Secretin : Dose Escalation within participant
|
|---|---|
|
Infections and infestations
Central line infection (coagulase negative S. Aureus infection with bacteremia)
|
100.0%
1/1 • Number of events 1
|
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Gastrointestinal disorders
Pain, nausea, vomitting
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
epigastrium and right upper quadrant pain
|
8.3%
1/12 • Number of events 1
|
Other adverse events
| Measure |
Human Secretin
n=12 participants at risk
Human Secretin : Dose Escalation within participant
|
|---|---|
|
Gastrointestinal disorders
nausea, mild
|
33.3%
4/12
|
|
Vascular disorders
mild flushing, upper body
|
50.0%
6/12
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place