Trial Outcomes & Findings for Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying (NCT NCT00685477)

Results Overview

The primary statistical endpoint was the CV as a measure of variability for the GBEF for each infusion method at the different intervals to determine which sincalide infusion method had the lowest variation. The CV is the SD divided by the mean and is expressed as a percentage and reflects the variability among the values. The infusion method having the lowest CV is considered best as it reflects the lowest variability of the values.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

15, 30, 45, and 60 minutes post drug infusion

Results posted on

2017-02-17

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Sequence ABC Drug given over 15 minutes infusion followed by infusion over 30 minutes, followed by infusion over 60 minutes	Experimental Sequence ACB Drug given over 15 minutes infusion followed by infusion over 60 minutes, followed by infusion over 30 minutes	Experimental Sequence BAC Drug given over 30 minutes infusion followed by infusion over 15 minutes, followed by infusion over 60 minutes	Experimental Sequence BCA Drug given over 30 minutes infusion followed by infusion over 60 minutes, followed by infusion over 15 minutes	Experimental Sequence CAB Drug given over 60 minutes infusion followed by infusion over 15 minutes, followed by infusion over 30 minutes	Experimental Sequence CBA Drug given over 60 minutes infusion followed by infusion over 30 minutes, followed by infusion over 15 minutes
Overall Study STARTED	10	10	10	10	10	10
Overall Study COMPLETED	10	10	10	10	10	10
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=60 Participants CCK-8 0.02 mg/kg over 15, 30 or 60 minutes: Drug will be given over infusions at different time periods. All participants received all treatments.
Age, Continuous	38 years STANDARD_DEVIATION 12 • n=5 Participants
Gender Female	32 Participants n=5 Participants
Gender Male	28 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 15, 30, 45, and 60 minutes post drug infusion

Population: Some participants were excluded from analyses due to location testing procedures

The primary statistical endpoint was the CV as a measure of variability for the GBEF for each infusion method at the different intervals to determine which sincalide infusion method had the lowest variation. The CV is the SD divided by the mean and is expressed as a percentage and reflects the variability among the values. The infusion method having the lowest CV is considered best as it reflects the lowest variability of the values.

Outcome measures

Outcome measures
Measure	15min Infusion n=60 Participants Drug given over 15 minutes infusion	30 Min Infusion n=60 Participants Drug given over 30 minutes infusion	60 Min Infusion n=60 Participants Drug given over 60 minutes infusion
Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method 45 min post infusion	39.91 percentage Interval 33.05 to 50.42	31.30 percentage Interval 25.91 to 39.53	24.00 percentage Interval 20.35 to 29.28
Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method 15 min post infusion	51.66 percentage Interval 43.79 to 63.01	62.75 percentage Interval 53.19 to 76.53	71.38 percentage Interval 60.52 to 87.08
Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method 30 min post infusion	40.46 percentage Interval 33.49 to 51.1	34.49 percentage Interval 29.23 to 42.06	35.81 percentage Interval 30.36 to 43.69
Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method 60 min post infusion	35.21 percentage Interval 29.15 to 44.48	29.11 percentage Interval 24.1 to 36.77	18.55 percentage Interval 15.73 to 22.64

SECONDARY outcome

Timeframe: 15, 30, 45 and 60 minutes post-infusion

Population: Some participants were excluded from analyses due to location testing procedures

Outcome measures

Outcome measures
Measure	15min Infusion n=60 Participants Drug given over 15 minutes infusion	30 Min Infusion n=60 Participants Drug given over 30 minutes infusion	60 Min Infusion n=60 Participants Drug given over 60 minutes infusion
Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method 15 minutes post-infusion	57 percentage Standard Deviation 29	44 percentage Standard Deviation 28	34 percentage Standard Deviation 24
Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method 30 minutes post-infusion	67 percentage Standard Deviation 27	71 percentage Standard Deviation 24	64 percentage Standard Deviation 23
Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method 45 minutes post-infusion	66 percentage Standard Deviation 26	73 percentage Standard Deviation 23	78 percentage Standard Deviation 19
Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method 60 minutes post-infusion	68 percentage Standard Deviation 24	74 percentage Standard Deviation 21	84 percentage Standard Deviation 16

Adverse Events

All Study Participants

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

Alan Maurer, MD

Temple University

Phone: 215-707-8269

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place