Bunionectomy Trial With GRT6005 | NCT00872885

Studies
Bunionectomy Trial With GRT6005

NCT00872885

Sponsor

Tris Pharma, Inc.

Status

Completed

Last Update Posted

Jul 15, 2021Actual

Enrollment

258Actual

Phase

Phase 2

Conditions

Post Operative Pain

Interventions

GRT6005
Morphine
Placebo

Countries

United States

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

ID	Type	Description	Link
KF5503/37	Other Identifier	Sponsor

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Mar 24, 2009

First Submission Date that Met QC Criteria

Mar 30, 2009

First Posted Date

Mar 31, 2009Estimated

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

Jun 11, 2010

Certification/Extension First Submitted that Passed QC Review

Jun 11, 2010

Certification/Extension First Posted Date

Jun 14, 2010Estimated

Last Update Submitted Date

Jul 13, 2021

Last Update Posted Date

Jul 15, 2021Actual

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 purpose of the trial is to determine whether the new centrally acting analgesic is effective in comparison to placebo and an active comparator (morphine).

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

258Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Dose 1	Drug: GRT6005
B	Experimental	Dose 2	Drug: GRT6005
C	Experimental	Dose 3	Drug: GRT6005
D	Active Comparator	Morphine	Drug: Morphine
E	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GRT6005	Drug	liquid formulation, 200 to 600 µg, single dose, one day	A B C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments		8 hours

Secondary Outcomes

Measure	Description	Time Frame
Amount of rescue medication		24 hours
Adverse events	Adverse Events reported by the participant as well as electrocardiogram, a measure of electrical activity of the heart and laboratory values

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects scheduled to undergo primary unilateral first metatarsal bunionectomy

Exclusion Criteria:

Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients.
Concomitant inflammatory disease.
Life-long history of seizure disorder or epilepsy.
Subjects with impaired renal function
Subjects with impaired hepatic function
Female subjects who are pregnant or breastfeeding.
Resting pulse rate is <50bpm or >100 bpm after 5 minutes rest in supine position
resting blood pressure after 5 minutes rest in supine position: Systolic blood pressure is <100mmHg or >140 mmHg Diastolic blood pressure is <60 mmHg or > 90 mmHg

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Bothmer, Dr.	Grünenthal GmbH	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Premier Research Group Ltd		Austin	Texas	78705	United States

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009020	Morphine

Ancestor Terms

ID	Term
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided