Trial · NCT03340675

Oral Ifetroban in Subjects With Duchenne Muscular Dystrophy

NCT03340675, Phase 2, Completed, Cumberland Pharmaceuticals; results first posted 2026-01-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Oral Ifetroban in Subjects With Duchenne Muscular Dystrophy. Trials, record NCT03340675. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03340675

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Trial

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

Title: Oral Ifetroban in Subjects With Duchenne Muscular Dystrophy
NCT number: NCT03340675
Status: Completed
Phases: Phase 2
Enrollment: 46 participants, actual
Lead sponsor: Cumberland Pharmaceuticals
Conditions: Duchenne Muscular Dystrophy Cardiomyopathy, Cardiomyopathy, Dilated
Interventions: Ifetroban, Placebo
First posted: 2017-11-13
Last updated: 2026-03-17
Results first posted: 2026-01-26

Source ClinicalTrials.gov

Registered outcomes15

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

List	Outcome	Time frame	Description
Primary	Incidence of Treatment-Emergent Adverse Events	Baseline through 12 months	Percentage of subjects with one or more treatment emergent adverse event
Secondary	Pharmacokinetics Area Under the Curve	Pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post-dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7	Plasma ifetroban and its acyl glucuronide metabolite were measured pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7. Area under the curve until the last measurement was calculated for the plasma concentration versus time curves for ifetroban and its acyl glucuronide metabolite after administration of assigned oral ifetroban dose
Secondary	Pharmacokinetics Maximum Serum Concentration (Cmax)	Pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7	Plasma ifetroban and its acyl glucuronide metabolite were measured pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7 to determine the maximum plasma concentration of ifetroban and its acyl glucuronide metabolite after administration of assigned oral ifetroban dose
Secondary	Pharmacokinetics Time to Reach Cmax (Tmax) Concentration	Pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7	Plasma ifetroban and its acyl glucuronide metabolite were measured pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7 to determine the time to maximum plasma concentration of ifetroban and its acyl glucuronide metabolite following administration of assigned oral ifetroban dose
Secondary	Pharmacokinetics Plasma Terminal Half-life Concentration	Pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7	Plasma ifetroban were measured pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7. The terminal elimination half-life was calculated from the plasma concentration versus time curves for ifetroban following administration of assigned oral ifetroban dose
Secondary	Change From Baseline in Left Ventricular Ejection Fraction	Baseline visit and Month 12 visit	Change from baseline at month 12 in left ventricular ejection fraction
Secondary	Change From Baseline in FEV1	Baseline through month 12	Change from baseline at month 12 in Forced Expiratory Volume in 1 second
Secondary	Change From Baseline in Percent Predicted FEV1	Baseline through month 12	Change from baseline at month 12 in percent predicted Forced Expiratory Volume in 1 second
Secondary	Change From Baseline in FVC	Baseline through month 12	Change from baseline at month 12 in Forced Vital Capacity
Secondary	Change From Baseline in Percent Predicted FVC	Baseline through month 12	Change from baseline at month 12 in percent predicted Forced Vital Capacity

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Treatment-Emergent Adverse Events	Baseline through 12 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pharmacokinetics Area Under the Curve	Pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post-dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7	Fewer participants are represented here due to missing assessments for this measure.	h*ng/mL	MEAN
SECONDARY	Pharmacokinetics Maximum Serum Concentration (Cmax)	Pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7	Fewer participants are represented here due to missing assessments for this measure.	ng/mL	MEAN
SECONDARY	Pharmacokinetics Time to Reach Cmax (Tmax) Concentration	Pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7	Fewer participants are represented here due to missing assessments for this measure.	h	MEAN
SECONDARY	Pharmacokinetics Plasma Terminal Half-life Concentration	Pre-dose and at 0.5, 1.0, 4.0, 8.0 and 24.0 h post dose on Day 0 and pre-dose and 0.5 h post-dose on Day 7	Fewer participants are represented here due to missing assessments for this measure.	h	MEAN
SECONDARY	Change From Baseline in Left Ventricular Ejection Fraction	Baseline visit and Month 12 visit	Differences in number of participants analyzed is due to missing evaluations at one or more timepoint	Percentage of LVEF	MEAN
SECONDARY	Change From Baseline in FEV1	Baseline through month 12	Differences in number of participants analyzed is due to missing evaluations at one or more timepoint	Liters	MEAN
SECONDARY	Change From Baseline in Percent Predicted FEV1	Baseline through month 12	Differences in number of participants analyzed is due to missing evaluations at one or more timepoint	Percent	MEAN
SECONDARY	Change From Baseline in FVC	Baseline through month 12	Differences in number of participants analyzed is due to missing evaluations at one or more timepoint	Liters	MEAN
SECONDARY	Change From Baseline in Percent Predicted FVC	Baseline through month 12	Differences in number of participants analyzed is due to missing evaluations at one or more timepoint	Percent	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group62

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

Outcome	Group	Category	Value	Spread	Units
Incidence of Treatment-Emergent Adverse Events	High Dose Ifetroban	Any TEAE	14		Participants
Incidence of Treatment-Emergent Adverse Events	Low Dose Ifetroban	Any TEAE	9		Participants
Incidence of Treatment-Emergent Adverse Events	Placebo	Any TEAE	10		Participants
Pharmacokinetics Area Under the Curve	High Dose Ifetroban	Ifetroban	3196	Standard Deviation 2485	h*ng/mL
Pharmacokinetics Area Under the Curve	Low Dose Ifetroban	Ifetroban	761	Standard Deviation 585	h*ng/mL
Pharmacokinetics Area Under the Curve	High Dose Ifetroban	Ifetroban Glucuronide	45116	Standard Deviation 30211	h*ng/mL
Pharmacokinetics Area Under the Curve	Low Dose Ifetroban	Ifetroban Glucuronide	13789	Standard Deviation 9700	h*ng/mL
Pharmacokinetics Maximum Serum Concentration (Cmax)	High Dose Ifetroban	Ifetroban	1560	Standard Deviation 2028	ng/mL
Pharmacokinetics Maximum Serum Concentration (Cmax)	Low Dose Ifetroban	Ifetroban	272	Standard Deviation 300	ng/mL
Pharmacokinetics Maximum Serum Concentration (Cmax)	High Dose Ifetroban	Ifetroban Glucuronide	9787	Standard Deviation 7148	ng/mL

1 to 10 of 62Source ClinicalTrials.gov

See all 62 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Double Blind	STARTED	High Dose Ifetroban	18
Double Blind	STARTED	Low Dose Ifetroban	12
Double Blind	STARTED	Placebo	11
Double Blind	COMPLETED	High Dose Ifetroban	13
Double Blind	COMPLETED	Low Dose Ifetroban	9
Double Blind	COMPLETED	Placebo	8
Double Blind	NOT COMPLETED	High Dose Ifetroban	5
Double Blind	NOT COMPLETED	Low Dose Ifetroban	3
Double Blind	NOT COMPLETED	Placebo	3
Open Label Extension	STARTED	High Dose Ifetroban	13

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events96

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
other	Nausea	Gastrointestinal disorders	High Dose Ifetroban	2	18
other	Nausea	Gastrointestinal disorders	Low Dose Ifetroban	2	12
other	Nausea	Gastrointestinal disorders	Placebo	3	11
other	Vomiting	Gastrointestinal disorders	High Dose Ifetroban	3	18
other	Vomiting	Gastrointestinal disorders	Low Dose Ifetroban	1	12
other	Vomiting	Gastrointestinal disorders	Placebo	2	11
other	Diarrhoea	Gastrointestinal disorders	High Dose Ifetroban	2	18
other	Diarrhoea	Gastrointestinal disorders	Low Dose Ifetroban	1	12
other	Diarrhoea	Gastrointestinal disorders	Placebo	1	11
other	Constipation	Gastrointestinal disorders	High Dose Ifetroban	1	18

1 to 10 of 96Source ClinicalTrials.gov

See all 96 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	High Dose Ifetroban	0	18
Total, all-cause mortality	Low Dose Ifetroban	0	12
Total, all-cause mortality	Placebo	0	11
Total, other adverse events	High Dose Ifetroban	14	18
Total, other adverse events	Low Dose Ifetroban	9	12
Total, other adverse events	Placebo	10	11
Total, serious adverse events	High Dose Ifetroban	3	18
Total, serious adverse events	Low Dose Ifetroban	2	12
Total, serious adverse events	Placebo	2	11

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34048282	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 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.

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