Trial Outcomes & Findings for Pentoxifylline Treatment of Acute Pancreatitis (NCT NCT01292005)

NCT ID: NCT01292005

Last Updated: 2016-10-25

Results Overview

C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The normal value range for CRP = 1-10 mg/L.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 28 participants
• Primary outcome timeframe: baseline, Day 1, Day 3
• Results posted on: 2016-10-25

Participant Flow

Subjects were enrolled from the Mayo Clinic in Rochester, Minnesota between 2009 and 2012.

30 subjects signed informed consent; two subjects were excluded after consent because they were found to be not eligible.

Participant milestones

Measure	Pentoxifylline Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.	Placebo Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
Overall Study STARTED	14	14
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pentoxifylline Treatment of Acute Pancreatitis

Baseline characteristics by cohort

Measure	Pentoxifylline n=14 Participants Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.	Placebo n=14 Participants Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.	Total n=28 Participants Total of all reporting groups
Age, Continuous	69 years n=5 Participants	58 years n=7 Participants	64 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants
Body Mass Index	30.2 kg/m^2 n=5 Participants	32.5 kg/m^2 n=7 Participants	30.3 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: baseline, Day 1, Day 3

C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The normal value range for CRP = 1-10 mg/L.

Outcome measures

Measure	Pentoxifylline n=14 Participants Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.	Placebo n=14 Participants Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
Change in C-Reactive Protein (CRP) Change from baseline to Day 1	48.4 mg/L Interval -37.1 to 207.3	60.6 mg/L Interval -71.0 to 283.2
Change in C-Reactive Protein (CRP) Change from baseline to Day 3	62 mg/L Interval -157.4 to 255.3	154 mg/L Interval -170.0 to 193.5

PRIMARY outcome

Timeframe: baseline, Day 1, Day 3

Normal value range for TNF alpha = 0 - 22 pg/ml.

Outcome measures

Measure	Pentoxifylline n=14 Participants Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.	Placebo n=14 Participants Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
Change in Tumor Necrosis Factor (TNF)-Alpha Change from baseline to Day 1	0 pg/ml Interval -1.2 to 0.52	-0.05 pg/ml Interval -0.9 to 49.2
Change in Tumor Necrosis Factor (TNF)-Alpha Change from baseline to Day 3	0.2 pg/ml Interval -1.0 to 0.5	-0.3 pg/ml Interval -3.5 to 17.2

PRIMARY outcome

Timeframe: baseline, Day 1, Day 3

Normal value range for IL-6 = 0 - 5 pg/ml.

Outcome measures

Measure	Pentoxifylline n=14 Participants Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.	Placebo n=14 Participants Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
Change in Interleukin (IL) IL-6 Change from baseline to Day 1	2.1 pg/ml Interval -37.0 to 25.0	0.7 pg/ml Interval -62.0 to 152.0
Change in Interleukin (IL) IL-6 Change from baseline to Day 2	-8.6 pg/ml Interval -61.0 to 15.6	-2.9 pg/ml Interval -213.0 to 65.8

PRIMARY outcome

Timeframe: baseline, Day 1, Day 3

Normal value range for IL-8 = 0 - 5 pg/ml.

Outcome measures

Measure	Pentoxifylline n=14 Participants Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.	Placebo n=14 Participants Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
Changes in Interleukin (IL) IL-8 Change from baseline to Day 1	-3.0 pg/ml Interval -7.2 to 30.8	-1.7 pg/ml Interval -38.2 to 49.2
Changes in Interleukin (IL) IL-8 Change from baseline to Day 3	0.35 pg/ml Interval -10.3 to 5.4	-1.9 pg/ml Interval -43.6 to 18.2

SECONDARY outcome

Timeframe: 1 week or until dismissal date whichever occurs earlier.

Outcome measures

Measure	Pentoxifylline n=14 Participants Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.	Placebo n=14 Participants Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
Number Of Subjects With New Onset Organ Failure During Hospitalization	0 participants	3 participants

SECONDARY outcome

Timeframe: 1 week or until dismissal date whichever occurs earlier

Outcome measures

Measure	Pentoxifylline n=14 Participants Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.	Placebo n=14 Participants Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization	0 participants	2 participants

SECONDARY outcome

Timeframe: 30 days or until dismissal date, whichever occurs earlier

"Lengthy" was defined as either greater than 4 days or greater than 10 days.

Outcome measures

Measure	Pentoxifylline n=14 Participants Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.	Placebo n=14 Participants Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
Number of Patients With Lengthy Hospital Stays Length of hospitalization >4 days	2 participants	8 participants
Number of Patients With Lengthy Hospital Stays Length of hospitalization >10 days	0 participants	5 participants

SECONDARY outcome

Timeframe: 30 days or until dismissal date, whichever occurs earlier

Outcome measures

Measure	Pentoxifylline n=14 Participants Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.	Placebo n=14 Participants Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
Length of Hospital Stay	3 days Interval 1.0 to 5.0	5 days Interval 1.0 to 30.0

SECONDARY outcome

Timeframe: 30 days or until dismissal date, whichever occurs earlier

Outcome measures

Measure	Pentoxifylline n=14 Participants Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.	Placebo n=14 Participants Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
Length of Intensive Care Unit (ICU) Stay	0 Days Interval 0.0 to 0.0	0 Days Interval 0.0 to 13.0

SECONDARY outcome

Timeframe: 30 days, or until dismissal, whichever came first

Outcome measures

Measure	Pentoxifylline n=14 Participants Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.	Placebo n=14 Participants Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
Number of Subjects Who Needed an Intensive Care Unit Stay	0 participants	4 participants

Adverse Events

Pentoxifylline

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

Dr. Santhi Swaroop Vege

Mayo Clinic

Phone: 507-284-2175

Email: vege.santhi@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place