Trial · NCT00848107

Open-Label Study of Oral Treprostinil in Digital Ulcers

NCT00848107, Phase 2, Terminated, United Therapeutics; results first posted 2014-02-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Open-Label Study of Oral Treprostinil in Digital Ulcers. Trials, record NCT00848107. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00848107

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Open-Label Study of Oral Treprostinil in Digital Ulcers
NCT number: NCT00848107
Status: Terminated
Phases: Phase 2
Enrollment: 115 participants, actual
Lead sponsor: United Therapeutics
Conditions: Systemic Sclerosis
Interventions: treprostinil diethanolamine
First posted: 2009-02-20
Last updated: 2024-06-18
Results first posted: 2014-02-07
Limitations and caveats: Interpretation of the change in digital ulcer status was limited by the lack of a control group and the discontinuation of the study prior to subjects completing all scheduled visits.

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Net Ulcer Burden- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment	Baseline and Months 1, 3, 6, 9, 12, and 18	Net ulcer burden at any given assessment was defined as the number of "new" or "active" ulcers at that assessment, plus the number of "indeterminate" ulcers at that assessment that had previously been classified as either "active" or "new" at any earlier assessment during the study. The mean change in net ulcer burden from time of study entry was summarized for each scheduled visit assessment.
Primary	Total Ulcer Number- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment	Baseline and Months 1, 3, 6, 9, 12, and 18	The total ulcer number includes all ulcers designated as "active", "indeterminate", or "new" for a given visit. The mean change in the total number of ulcers present from time of study entry was summarized for each scheduled visit assessment.
Primary	Formation of New Ulcers	18 months (or last study visit)	The number and percentage of subjects who developed new ulcers during the study were summarized.
Secondary	Patient Function and QOL Measure: Scleroderma Health Assessments Questionnaire (SHAQ)- Mean Change From Study Entry in SHAQ Component Scores at Each Scheduled Assessment	Baseline and Months 1, 3, 6, and 12	The SHAQ consists of 20 health assessment questionnaire questions with integer responses of 0 (without any difficulty) to 3 (unable to do), and five scleroderma-specific visual analog scale (VAS) domains (Overall Disease Activity, Raynaud's Phenomenon, Finger Ulcers, Breathing, and Intestinal Problems) with values ranging from 0.0 to 15.0 centimeters. The questions are divided into eight component domains: Dressing \& Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each domain score is calculated by summing the domain responses and dividing by the number of questions in that domain. Each VAS domain score is calculated by dividing the value in centimeters by 5. SHAQ component and VAS domain score ranges from 0 (least limitation) to 3 (most limitation). The aggregate SHAQ score is calculated by dividing the sum of all domain scores by 13, with a score ranging from 0 (least limitation) to 3 (most limitation).
Secondary	Patient Function and Quality of Life Measure: Cochin Hand Function Scale (CHFS)-Mean Change From Study Entry in CHFS Score at Each Scheduled Assessment	Baseline and Months 1, 3, 6, and 12	The CHFS score is derived from 18 validated questions that assess functional disability and handicap due to hand involvement in rheumatoid arthritis. Each answer is scored on a scale with possible integer responses of 0(without difficulty) to 5 (impossible). The CHFS score is simply the sum of all 18 questions, divided by the number of questions actually answered, multiplied by 18. At least 10 of the 18 questions must have been answered in order for CHFS to be calculated. Therefore, CHFS score values can range from 0 (least limitation) to 90 (most limitation), with improvements in function or reduction of limitation indicated a decreased score value. The mean change from study entry in CHFS scores at each scheduled assessment are summarized.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Patient Function and QOL Measure: Scleroderma Health Assessments Questionnaire (SHAQ)- Mean Change From Study Entry in SHAQ Component Scores at Each Scheduled Assessment	Baseline and Months 1, 3, 6, and 12	Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.	units on a scale	MEAN
PRIMARY	Net Ulcer Burden- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment	Baseline and Months 1, 3, 6, 9, 12, and 18	Efficacy was assessed using data obtained at each visit, if available, from all subjects enrolled in this study. Assessments performed after discontinuation of study drug were excluded from the summaries.	ulcers	MEAN
SECONDARY	Patient Function and Quality of Life Measure: Cochin Hand Function Scale (CHFS)-Mean Change From Study Entry in CHFS Score at Each Scheduled Assessment	Baseline and Months 1, 3, 6, and 12	Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.	units on a scale	MEAN
PRIMARY	Total Ulcer Number- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment	Baseline and Months 1, 3, 6, 9, 12, and 18	Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.	number of ulcers	MEAN
PRIMARY	Formation of New Ulcers	18 months (or last study visit)	Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.	participants	NUMBER

Source ClinicalTrials.gov

Results by group23

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Patient Function and QOL Measure: Scleroderma Health Assessments Questionnaire (SHAQ)- Mean Change From Study Entry in SHAQ Component Scores at Each Scheduled Assessment	Oral Treprostinil Diethanolamine	Month 1	-0.01	Standard Deviation 0.21	units on a scale
Patient Function and QOL Measure: Scleroderma Health Assessments Questionnaire (SHAQ)- Mean Change From Study Entry in SHAQ Component Scores at Each Scheduled Assessment	Oral Treprostinil Diethanolamine	Month 3	0.02	Standard Deviation 0.23	units on a scale
Patient Function and QOL Measure: Scleroderma Health Assessments Questionnaire (SHAQ)- Mean Change From Study Entry in SHAQ Component Scores at Each Scheduled Assessment	Oral Treprostinil Diethanolamine	Month 6	0.02	Standard Deviation 0.28	units on a scale
Patient Function and QOL Measure: Scleroderma Health Assessments Questionnaire (SHAQ)- Mean Change From Study Entry in SHAQ Component Scores at Each Scheduled Assessment	Oral Treprostinil Diethanolamine	Month 12	-0.04	Standard Deviation 0.27	units on a scale
Net Ulcer Burden- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment	Oral Treprostinil Diethanolamine	Month 1	-0.77	Standard Deviation 1.61	ulcers
Net Ulcer Burden- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment	Oral Treprostinil Diethanolamine	Month 3	-0.52	Standard Deviation 2.02	ulcers
Net Ulcer Burden- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment	Oral Treprostinil Diethanolamine	Month 6	-0.32	Standard Deviation 1.19	ulcers
Net Ulcer Burden- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment	Oral Treprostinil Diethanolamine	Month 9	-0.52	Standard Deviation 1.53	ulcers
Net Ulcer Burden- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment	Oral Treprostinil Diethanolamine	Month 12	-0.64	Standard Deviation 1.20	ulcers
Net Ulcer Burden- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment	Oral Treprostinil Diethanolamine	Month 18	-1.67	Standard Deviation 0.58	ulcers

1 to 10 of 23Source ClinicalTrials.gov

See all 23 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Oral Treprostinil Diethanolamine	115
Overall Study	COMPLETED	Oral Treprostinil Diethanolamine	94
Overall Study	NOT COMPLETED	Oral Treprostinil Diethanolamine	21

Source ClinicalTrials.gov

Adverse events63

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	Headache	Nervous system disorders	Oral Treprostinil Diethanolamine	74	115	99
other	Dizziness	Nervous system disorders	Oral Treprostinil Diethanolamine	22	115	24
other	Migraine	Nervous system disorders	Oral Treprostinil Diethanolamine	8	115	12
other	Diarrhea	Gastrointestinal disorders	Oral Treprostinil Diethanolamine	52	115	77
other	Nausea	Gastrointestinal disorders	Oral Treprostinil Diethanolamine	39	115	53
other	Vomiting	Gastrointestinal disorders	Oral Treprostinil Diethanolamine	15	115	20
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	Oral Treprostinil Diethanolamine	12	115	13
other	Constipation	Gastrointestinal disorders	Oral Treprostinil Diethanolamine	9	115	9
other	Abdominal discomfort	Gastrointestinal disorders	Oral Treprostinil Diethanolamine	7	115	10
other	Abdominal pain upper	Gastrointestinal disorders	Oral Treprostinil Diethanolamine	7	115	9

1 to 10 of 63Source ClinicalTrials.gov

See all 63 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oral Treprostinil Diethanolamine
Total, other adverse events	Oral Treprostinil Diethanolamine	113	115
Total, serious adverse events	Oral Treprostinil Diethanolamine	17	115

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00848107

GET https://conductscience.org/api/trials/v1/NCT00848107/results?page=2

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