Study of Integrity of Down Inhibitor Bundle at Patients S... | NCT01053845

Studies
Study of Integrity of Down Inhibitor Bundle at Patients Suffering of Neuropathic Pain

NCT01053845

Sponsor

University Hospital, Clermont-Ferrand

Status

Completed

Last Update Posted

Jul 8, 2014Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Healthy Volunteers
Patients Suffering of Peripheral Neuropathic Pain

Interventions

Neuropathic pain

Countries

France

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
2009-A00155-52	Registry Identifier	ID RCB

Status Module

Record Verification Date

Jul 2014

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 2010

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Jan 19, 2010

First Submission Date that Met QC Criteria

Jan 19, 2010

First Posted Date

Jan 21, 2010Estimated

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 4, 2014

Last Update Posted Date

Jul 8, 2014Estimated

Name	Class
Grünenthal GmbH	INDUSTRY

Description Module

Brief Summary

Several studies showed that activity of down inhibitor bundle is weakened in different painful pathologies as the fibromyalgy or the trigeminal nevralgy.

The purpose of the protocol is to study the working of down inhibitor bundle at patients suffering of neuropathic pain.

Detailed Description

Prospective study with comparison groups

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuropathic pain	Other	to study the working of down inhibitor bundle at patients suffering of neuropathic pain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of the amplitude of N2P2 waves between healthy volunteers and patients suffering of peripheral neuropathic pain.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

neuropathic patients group
- Patient suffering of peripheral neuropathic pain
- 18 years old women or men at least

Exclusion Criteria:

• Healthy volunteers
- 18 years old women or men at least

Accepts Healthy Volunteers

Yes

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
Gisèle Pickering, Dr	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Clermont-Ferrand		Clermont-Ferrand		63003	France

Condition Browse Module

MeSH Terms

ID	Term
D009437	Neuralgia

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided