Safety and Efficacy of Anorectal Application of Dx-gel fo... | NCT01380132

Studies
Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence

NCT01380132

Sponsor

Uppsala University Hospital

Status

Completed

Last Update Posted

Jun 28, 2011Estimated

Enrollment

35Actual

Phase

Phase 1Phase 2

Conditions

Fecal Incontinence

Interventions

Anal injection of Nasha Dx

Countries

Sweden

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
03 464	Other Identifier	EPN Uppsala

Status Module

Record Verification Date

Feb 2010

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

Feb 2004

Primary Completion Date

Jan 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Jun 21, 2011

First Submission Date that Met QC Criteria

Jun 23, 2011

First Posted Date

Jun 27, 2011Estimated

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

Jun 27, 2011

Last Update Posted Date

Jun 28, 2011Estimated

Name	Class
Galderma R&D	INDUSTRY

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 study is to determine whether anorectal application of Nasha Dx is safe and effective for treatment of anal incontinence.

Detailed Description

Patients not fully improved after 1:st injection were offered reinjection after 4-6 weeks.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anal injection of Nasha Dx	Experimental		Procedure: Anal injection of Nasha Dx

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anal injection of Nasha Dx	Procedure	Submucous injection of Nasha Dx 5-10 mm above dentate line	Anal injection of Nasha Dx

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment response as measured by a 50% reduction in no of incontinence episodes.		One year posttreatment

Secondary Outcomes

Measure	Description	Time Frame
Adverse events		One year posttreatment
Global assessment	Graded by the patient as excellent, good, fair or poor	One year posttreatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Incontinence to loose or solid stool at least once weekly (Millers incontinence score 6-12).
Age 18-80
Available for follow-up for the duration of the study
Written informed consent.

Exclusion Criteria:

Sphincter defect visible on anal ultrasound.
Pregnancy.
Rectal prolapse or inflammatory bowel disease.
Recent (within 6 months) anal surgery except for haemorrhoids.
Anorectal sepsis.
Anticoagulant medication or bleeding diathesis.

Accepts Healthy Volunteers

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 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
Wilhelm JR Graf, Prof.	Inst of Surgical Sciences, Uppsala university	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery, University Hospital		751 82 Uppsala			Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19581853	Result	Danielson J, Karlbom U, Sonesson AC, Wester T, Graf W. Submucosal injection of stabilized nonanimal hyaluronic acid with dextranomer: a new treatment option for fecal incontinence. Dis Colon Rectum. 2009 Jun;52(6):1101-6. doi: 10.1007/DCR.0b013e31819f5cbf.

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases