Trial · NCT00590161
Pentoxifylline in Patients With Nonalcoholic Steatohepatitis
NCT00590161, Phase 2, Completed, Case Western Reserve University; results first posted 2013-09-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pentoxifylline in Patients With Nonalcoholic Steatohepatitis. Trials, record NCT00590161. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00590161
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pentoxifylline in Patients With Nonalcoholic Steatohepatitis
- NCT number
- NCT00590161
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 55 participants, actual
- Lead sponsor
- Case Western Reserve University
- Conditions
- Nonalcoholic Steatohepatitis
- Interventions
- pentoxifylline (PTX), placebo
- First posted
- 2008-01-10
- Last updated
- 2013-09-26
- Results first posted
- 2013-09-26
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Histological Improvement of at Least 2 Points in NAFLD Activity Score (NAS) on Liver Biopsy After One Year. | 1 year (Baseline liver biopsy done at study entry, and subsequent liver biopsy done after one year of therapy with pentoxifylline or placebo) | The NAFLD Activity Score (NAS) grades NAFLD on liver biopsy based on the individual scoring of steatosis, inflammation and balloning. The NAS is assessed on a scale of 0 to 8 with higher scores indicating more severe disease and lower scores indicating less severe disease. NAS is obtained by adding steatosis(assessed on a scale of 0 to 3), inflammation (assessed on a scale of 0 to 3) and ballooning (assessed on a scale of 0 to 2). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Histological Improvement of at Least 2 Points in NAFLD Activity Score (NAS) on Liver Biopsy After One Year. | 1 year (Baseline liver biopsy done at study entry, and subsequent liver biopsy done after one year of therapy with pentoxifylline or placebo) | Intention to treat analysis included all participants and for this analysis patients without available end of study liver biopsy were imputed as treatment failures. Results showed here are continuous variable analysis of NAS score change in patients with available end of study liver biopsy (per protocol analysis) | NAS score units | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Histological Improvement of at Least 2 Points in NAFLD Activity Score (NAS) on Liver Biopsy After One Year. | Pentoxifylline 400 mg PO Tid | -1.6 | Standard Deviation 1.1 | NAS score units | |
| Histological Improvement of at Least 2 Points in NAFLD Activity Score (NAS) on Liver Biopsy After One Year. | Placebo Tid | -0.1 | Standard Deviation 1.4 | NAS score units |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pentoxifylline (PTX) 400 mg PO Three Times Daily (TID) | 26 | |
| Overall Study | STARTED | Placebo TID | 29 | |
| Overall Study | COMPLETED | Pentoxifylline (PTX) 400 mg PO Three Times Daily (TID) | 23 | |
| Overall Study | COMPLETED | Placebo TID | 26 | |
| Overall Study | NOT COMPLETED | Pentoxifylline (PTX) 400 mg PO Three Times Daily (TID) | 3 | |
| Overall Study | NOT COMPLETED | Placebo TID | 3 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Pentoxifylline 400 mg PO Tid | 6 | 26 | 6 |
| other | Nausea | Gastrointestinal disorders | Placebo Tid | 4 | 29 | 4 |
| other | Bloating | Gastrointestinal disorders | Pentoxifylline 400 mg PO Tid | 2 | 26 | 2 |
| other | Bloating | Gastrointestinal disorders | Placebo Tid | 3 | 29 | 3 |
| other | Headache | General disorders | Pentoxifylline 400 mg PO Tid | 2 | 26 | 2 |
| other | Headache | General disorders | Placebo Tid | 1 | 29 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Pentoxifylline 400 mg PO Tid | 0 | 26 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo Tid | 2 | 29 | 2 |
| other | Lightheadedness | General disorders | Pentoxifylline 400 mg PO Tid | 1 | 26 | 1 |
| other | Lightheadedness | General disorders | Placebo Tid | 3 | 29 | 3 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pentoxifylline 400 mg PO Tid | ||
| Total, all-cause mortality | Placebo Tid | ||
| Total, other adverse events | Pentoxifylline 400 mg PO Tid | 11 | 26 |
| Total, other adverse events | Placebo Tid | 14 | 29 |
| Total, serious adverse events | Pentoxifylline 400 mg PO Tid | 0 | 26 |
| Total, serious adverse events | Placebo Tid | 0 | 29 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21748765 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pentoxifylline 400 mg PO Tid vs Placebo Tid: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00590161
GET https://conductscience.org/api/trials/v1/NCT00590161/registered