NCT02748525: Milk

Evaluation of Gallbladder Contractility Using Both CCK and Milk Consecutively

Completed Phase 4 Results posted Last updated 2 July 2019

What this trial tests

Phase 4 trial testing Milk in Abdominal Pain in 50 participants. Completed in 14 June 2018.

Timeline

3 May 2016

Primary endpoint
14 June 2018

14 June 2018

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	50
Start date	3 May 2016
Primary completion	14 June 2018
Estimated completion	14 June 2018
Sites	1 location across United States

Drugs / interventions tested

• Milk
• CCK — full drug profile →

Conditions studied

• Abdominal Pain — all drugs for Abdominal Pain →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

Adults 18 to 80, any sex, with Abdominal Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Gallbladder Ejection Fraction Primary · 30 minutes after CCK administration

Patient will receive CCK, be scanned, and the ejection fraction will be measured.

Group	Value	95% CI
CCK Then Milk	15	0 – 33

Gallbladder Ejection Fraction Primary · 45 minutes after milk administration

Patient will receive CCK, be scanned, and the ejection fraction will be measured. Then milk will be administered, repeat scan and ejection fraction will be measured.

Group	Value	95% CI
CCK Then Milk	30	2 – 88

Number of Participants Who Reported Abdominal Pain at 6 Months Secondary · 6 months

Significant pain scale at follow up was defined as 5 or greater on a scale of 0-10, with 10 being the most severe pain.

Group	Value	95% CI
CCK Then Milk	6

Number of Participants Who Received Cholecystectomy Secondary · 6 months

Group	Value	95% CI
CCK Then Milk	18

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CCK Then Milk

Serious: 0/50 (0%)

Deaths: 0/50

Other adverse events (1 terms — click to expand)

Reaction	System	CCK Then Milk
Abdominal Pain	Hepatobiliary disorders	—

Data from ClinicalTrials.gov NCT02748525 adverse events section.

Sponsor's own description

This study aims to combine the use of IV CCK administration followed by oral milk during a HIDA scan to further stimulate the gallbladder contractility and decrease the number of false abnormal HIDA scans and unnecessary cholecystectomies in some patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.