Trial Outcomes & Findings for The Effects of Pentoxifylline on PAI-1 in an Obese Population (NCT NCT00770328)

NCT ID: NCT00770328

Last Updated: 2017-11-30

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 37 participants
• Primary outcome timeframe: Baseline and 8 weeks
• Results posted on: 2017-11-30

Participant Flow

Participant milestones

Measure	Pentoxifylline Patients receive Pentoxifylline 400 mg po TID for 8 weeks. Pentoxifylline: 400mg PO TID x 8 weeks	Placebo Patients take a placebo TID for 8 weeks. Placebo: PO TID x 8 weeks
Overall Study STARTED	22	15
Overall Study COMPLETED	9	11
Overall Study NOT COMPLETED	13	4

Reasons for withdrawal

Measure	Pentoxifylline Patients receive Pentoxifylline 400 mg po TID for 8 weeks. Pentoxifylline: 400mg PO TID x 8 weeks	Placebo Patients take a placebo TID for 8 weeks. Placebo: PO TID x 8 weeks
Overall Study Adverse Event	11	2
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

Study was completed and submitted for publication in 2011. We do not have the complete data set to answer questions about patients who did not complete the study.

Baseline characteristics by cohort

Measure	Pentoxifylline n=22 Participants Patients receive Pentoxifylline 400 mg po TID for 8 weeks. Pentoxifylline: 400mg PO TID x 8 weeks	Placebo n=15 Participants Patients take a placebo TID for 8 weeks. Placebo: PO TID x 8 weeks	Total n=37 Participants Total of all reporting groups
Age, Continuous	37.7 years STANDARD_DEVIATION 3.1 • n=9 Participants • Study was completed and submitted for publication in 2011. We do not have the complete data set to answer questions about patients who did not complete the study.	38.6 years STANDARD_DEVIATION 2.5 • n=11 Participants • Study was completed and submitted for publication in 2011. We do not have the complete data set to answer questions about patients who did not complete the study.	38.2 years STANDARD_DEVIATION 1.9 • n=20 Participants • Study was completed and submitted for publication in 2011. We do not have the complete data set to answer questions about patients who did not complete the study.
Sex: Female, Male Female	5 Participants n=9 Participants • Study submitted for publication in 2011. Records no longer exist to answer questions about screen failures and dropouts.	5 Participants n=11 Participants • Study submitted for publication in 2011. Records no longer exist to answer questions about screen failures and dropouts.	10 Participants n=20 Participants • Study submitted for publication in 2011. Records no longer exist to answer questions about screen failures and dropouts.
Sex: Female, Male Male	4 Participants n=9 Participants • Study submitted for publication in 2011. Records no longer exist to answer questions about screen failures and dropouts.	6 Participants n=11 Participants • Study submitted for publication in 2011. Records no longer exist to answer questions about screen failures and dropouts.	10 Participants n=20 Participants • Study submitted for publication in 2011. Records no longer exist to answer questions about screen failures and dropouts.
Region of Enrollment United States	22 participants n=22 Participants	15 participants n=15 Participants	37 participants n=37 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Measure	Pentoxifylline n=9 Participants Patients receive Pentoxifylline 400 mg po TID for 8 weeks. Pentoxifylline: 400mg PO TID x 8 weeks	Placebo n=11 Participants Patients take a placebo TID for 8 weeks. Placebo: PO TID x 8 weeks
Change in PAI-1 Level Baseline	39.5 ng/ml Standard Error 8.3	31.6 ng/ml Standard Error 7.6
Change in PAI-1 Level 8 Weeks	28.6 ng/ml Standard Error 7.7	37.9 ng/ml Standard Error 8.5

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Outcome measures

Measure	Pentoxifylline n=9 Participants Patients receive Pentoxifylline 400 mg po TID for 8 weeks. Pentoxifylline: 400mg PO TID x 8 weeks	Placebo n=11 Participants Patients take a placebo TID for 8 weeks. Placebo: PO TID x 8 weeks
Change in CRP Level 8 weeks	4.6 mg/dl Standard Error 1.9	2.4 mg/dl Standard Error 0.5
Change in CRP Level Baseline	5.2 mg/dl Standard Error 2.5	2.9 mg/dl Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: TNF-a assay did not work properly. Meaningless data resulted including negative values which are impossible.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: Unable to complete analysis due to TNF-a assay failure (see Outcome measure #3)

Outcome measures

Outcome data not reported

Adverse Events

Pentoxifylline

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pentoxifylline n=22 participants at risk Patients receive Pentoxifylline 400 mg po TID for 8 weeks. Pentoxifylline: 400mg PO TID x 8 weeks	Placebo n=15 participants at risk Patients take a placebo TID for 8 weeks. Placebo: PO TID x 8 weeks
Gastrointestinal disorders Nausea/Vomiting	50.0% 11/22 • Number of events 11 • The subjects were followed from baseline to 8 weeks.	0.00% 0/15 • The subjects were followed from baseline to 8 weeks.
Immune system disorders Allergic Reaction	0.00% 0/22 • The subjects were followed from baseline to 8 weeks.	6.7% 1/15 • Number of events 1 • The subjects were followed from baseline to 8 weeks.
Gastrointestinal disorders Bloating	0.00% 0/22 • The subjects were followed from baseline to 8 weeks.	6.7% 1/15 • Number of events 1 • The subjects were followed from baseline to 8 weeks.

Additional Information

James Muldowney

Vanderbilt University Medical Center

Phone: 615-936-1720

Email: james.muldowney@vanderbilt.edu

Results disclosure agreements

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