Painful Diabetic Polyneuropathy Trial With a New Centrall... | NCT00878293

Studies
Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic

NCT00878293

Sponsor

Tris Pharma, Inc.

Status

Completed

Last Update Posted

Jul 15, 2021Actual

Enrollment

90Actual

Phase

Phase 2

Conditions

Diabetic Polyneuropathy

Interventions

GRT6005
MS Continus®
Placebo

Countries

Germany
United Kingdom

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

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

Apr 2009

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Apr 3, 2009

First Submission Date that Met QC Criteria

Apr 7, 2009

First Posted Date

Apr 8, 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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

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 this trial is to determine whether the new centrally active analgesic and MS Continus® are effective in the treatment of painful diabetic polyneuropathy.

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

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Dose 1, 40 µg	Drug: GRT6005
B	Experimental	Dose 2, 120 µg	Drug: GRT6005
C	Experimental	Dose 3	Drug: GRT6005
D	Experimental	Dose 4	Drug: GRT6005
E	Experimental	Dose 5	Drug: GRT6005
F	Experimental	Dose 6	Drug: GRT6005
G	Experimental	Dose 7

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GRT6005	Drug	liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days	A B C D E

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average daily pain intensity		5 days

Secondary Outcomes

Measure	Description	Time Frame
Quality of life Neuropathic pain scale Amount and first time of Rescue medication Adverse events, ECG, Laboratory values		5 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with pain at least NRS >4 due to painful diabetic polyneuropaty.

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.
non Caucasian or Hispanic.
Concomitant painful disease.
Life-long history of seizure disorder or epilepsy.
Subjects with clinical relevant cardiac and vascular diseases.
Subjects with impaired renal function
Subjects with impaired hepatic function
Female subjects who are pregnant or breastfeeding.

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
Thomas Forst, Prof. Dr. med	IKFE, Parcusstr. 8, 55116 Mainz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Investigator 3		Bad Oeynhausen			Germany
Investigator 1

Condition Browse Module

MeSH Terms

ID	Term
D003929	Diabetic Neuropathies
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D048909	Diabetes Complications

Browse Leaves

Not provided

Browse Branches

Not provided