Trial Outcomes & Findings for A Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers (NCT NCT01087801)

Results Overview

Is Volume ≥ 3.5 mL Is HCO3 concentration ≥ 40 mEq/L Is DNA mutational analysis (K-ras-2 gene Fluorescence peak height ≥ 50 Relative Florescence Units panel assessable markers informative ≥ 8). (Note- The outcome value is boolean (yes or no) as an answer).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

64 participants

Primary outcome timeframe

First 5 minutes after treatment administration

Results posted on

2011-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	ChiRhoStim Human Secretin for Injection 0.1 mL/kg IV	Placebo Saline for Injection 0.1 mL/kg IV
Overall Study STARTED	30	34
Overall Study COMPLETED	26	29
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ChiRhoStim n=26 Participants Human Secretin for Injection 0.1 mL/kg IV	Placebo n=29 Participants Saline for Injection 0.1 mL/kg IV	Total n=55 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	27 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age Continuous	49.6 years STANDARD_DEVIATION 15.5 • n=5 Participants	47.2 years STANDARD_DEVIATION 12.3 • n=7 Participants	48.3 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	29 participants n=7 Participants	55 participants n=5 Participants

PRIMARY outcome

Timeframe: First 5 minutes after treatment administration

Is Volume ≥ 3.5 mL Is HCO3 concentration ≥ 40 mEq/L Is DNA mutational analysis (K-ras-2 gene Fluorescence peak height ≥ 50 Relative Florescence Units panel assessable markers informative ≥ 8). (Note- The outcome value is boolean (yes or no) as an answer).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: First 5 minutes after treatment administration

Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid.

Outcome measures

Outcome measures
Measure	ChiRhoStim n=26 Participants Human Secretin for Injection 0.1 mL/kg IV	Placebo n=29 Participants Saline for Injection 0.1 mL/kg IV
Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no). Yes	25 Participants	2 Participants
Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no). No	1 Participants	27 Participants

Adverse Events

ChiRhoStim

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Edward Purich, Ph.D.

ChiRhoClin, Inc.

Phone: 301-476-8388

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place