Hypotonic Treprostinil Subcutaneous Infusion for Control... | NCT01615627

Studies
Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain

NCT01615627

Sponsor

Jewish General Hospital

Status

Withdrawn

Last Update Posted

Mar 3, 2020Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Pulmonary Arterial Hypertension

Interventions

HypotonicTreprostinil Solution
Eutonic Treprostinil Solution

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No enrollment

Expanded Access Info

Start Date

Jul 1, 2012Actual

Primary Completion Date

Feb 28, 2019Actual

Completion Date

Feb 28, 2019Actual

First Submitted Date

Jun 6, 2012

First Submission Date that Met QC Criteria

Jun 7, 2012

First Posted Date

Jun 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 29, 2020

Last Update Posted Date

Mar 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators will test whether hypotonic (diluted) remodulin solution causes less pain than the eutonic (undiluted) solution supplied by the manufacturer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypotonic Treprostinil Solution	Experimental	Hypotonic Treprostinil Solution	Drug: HypotonicTreprostinil Solution
Eutonic Treprostinil Solution	Active Comparator	Eutonic Treprostinil Solution	Drug: Eutonic Treprostinil Solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HypotonicTreprostinil Solution	Drug	Hypotonic Treprostinil Solution	Hypotonic Treprostinil Solution

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Daily Pain Diary		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
McGill Pain Questionnaire		2 weeks
CAMPHOR quality of life questionnaire		2 weeks
6 minute walk distance

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

PAH by standard criteria
Treatment with subcutaneous remodulin infusion for at least 3 months, with stable dose for 1 month
Pain at infusion site (defined as > 8 on McGill Pain Questionnaire)

Exclusion Criteria:

Known pregnancy or breastfeeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Langleben, MD	Jewish General Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jewish General Hospital		Montreal	Quebec	H3T 1E2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D000081029	Pulmonary Arterial Hypertension

Ancestor Terms

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided