Clinical trialPhase 3Completed
Pentoxifylline Treatment in Acute Pancreatitis (AP)
Pentoxifylline Treatment in Acute Pancreatitis: A Double-Blind Placebo - Controlled Randomized Trial
- Outcome
- Outcome unknown
- Phase
- Phase 3
- Status
- Completed
- Study type
- Interventional
- Start
- May 2015
- Expected end
- 31 October 2017
- Enrollment
- 83 participants
- Sites
- 1
- Primary outcomes
- Change in C-reactive Protein (C-RP) From Admission Baseline at One Week.; Change in Tumor Necrosis Factor-alpha (TNF-a) Levels From Admission Baseline at One Week.; Change in Interleukin-6 (IL-6) Levels From Admission Baseline at One Week.; Change in Interleukin-8 (IL-8) Levels From Admission Baseline at One Week.
- Sponsor
- Other
- Results posted
- 2019-01-23
- Last update
- 23 January 2019
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Brief summary public domain (ClinicalTrials.gov)
The purpose of this study was to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis.
Detailed description public domain (ClinicalTrials.gov)
Participants were randomized to either the treatment group (Pentoxifylline medication) or the control group (Placebo). Participant took a pill orally, starting from the time of admission. Participants received a total of 9 doses over the three days of hospitalization (72 hours). Research blood draws were done at baseline and on 5 successive days or until the time of discharge, whichever occured earlier. The study gathered clinical follow up information up to 4 months following hospitalization regarding the diagnosis of acute pancreatitis.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Change in C-reactive Protein (C-RP) From Admission Baseline at One Week. [Admission (baseline), day 5]. Mean, mg/L (Standard Deviation). Admission (baseline): Pentoxifylline (n=45): 86.2 (81.5); Placebo (n=38): 75.8 (83.1). Day 5: Pentoxifylline (n=45): 116.4 (100.4); Placebo (n=38): 127.2 (97.8). Analysis, Pentoxifylline vs Placebo: p=0.5796; Kruskal-Wallis; superiority. Analysis, Pentoxifylline vs Placebo: p=0.8415; Kruskal-Wallis; superiority.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Change in Tumor Necrosis Factor-alpha (TNF-a) Levels From Admission Baseline at One Week. [Admission (baseline), day 5]. Mean, pg/ml (Standard Deviation). Admission (baseline): Pentoxifylline (n=40): 1.9 (0.9); Placebo (n=37): 1.8 (1.3). Day 5: Pentoxifylline (n=40): 4.3 (6.3); Placebo (n=37): 1.9 (0.7). Analysis, Pentoxifylline vs Placebo: p=0.1109; Kruskal-Wallis; superiority. Analysis, Pentoxifylline vs Placebo: p=0.4619; Kruskal-Wallis; superiority.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Change in Interleukin-6 (IL-6) Levels From Admission Baseline at One Week. [Admission (baseline), day 5]. Mean, pg/mL (Standard Deviation). Admission (baseline): Pentoxifylline (n=42): 107.9 (124.8); Placebo (n=35): 89.1 (138.2). Day 5: Pentoxifylline (n=42): 81.8 (97.4); Placebo (n=35): 88.6 (85.2). Analysis, Pentoxifylline vs Placebo: p=0.1236; Kruskal-Wallis; superiority. Analysis, Pentoxifylline vs Placebo: p=0.9468; Kruskal-Wallis; superiority.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Change in Interleukin-8 (IL-8) Levels From Admission Baseline at One Week. [Admission (baseline), day 5]. Mean, pg/ml (Standard Deviation). Admission (baseline): Pentoxifylline (n=42): 43.7 (29.4); Placebo (n=36): 31.5 (26.1). Day 5: Pentoxifylline (n=42): 45.9 (43.2); Placebo (n=36): 32.1 (23.5). Analysis, Pentoxifylline vs Placebo: p=0.157; Kruskal-Wallis; superiority. Analysis, Pentoxifylline vs Placebo: p=0.3173; Kruskal-Wallis; superiority.