Does Visceral Manipulation Works in Treating Functional D... | NCT01021475

Studies
Does Visceral Manipulation Works in Treating Functional Dyspepsia?

NCT01021475

Sponsor

International College of Osteopathic Medicine

Status

Unknown status

Last Update Posted

Nov 30, 2009Estimated

Enrollment

50Estimated

Phase

Phase 1

Conditions

Functional Dyspepsia

Interventions

Visceral Manipulation
PPIs and/or Domperidone

Countries

Italy

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

Nov 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Nov 2010Estimated

Completion Date

Not provided

First Submitted Date

Nov 27, 2009

First Submission Date that Met QC Criteria

Nov 27, 2009

First Posted Date

Nov 30, 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

Nov 27, 2009

Last Update Posted Date

Nov 30, 2009Estimated

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 goal of this study is to determine if Visceral Manipulation (VM) is effective in treating Functional Dyspepsia in addition to drug therapy.

Null hypothesis is that VM does not influence FD symptoms.

Detailed Description

50 patients with Functional Dyspepsia (FD) diagnosed by General Practitioners are randomized in two therapy group: 1) drug only group and 2) drug + Visceral Manipulation group. Group 1 receive drug therapy for 4 weeks, Group 2 receive drug therapy for 4 weeks and 4 Visceral Manipulation visits with weekly frequency (visit 1 at day 1 of drug therapy). FD symptoms are recorded with VAS at baseline and after 1 and 4 weeks of therapy, and after 8 weeks (4 weeks after the finish of all therapies).

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usual drug FD therapy + Visceral Manipulation	Experimental		Procedure: Visceral Manipulation
Usual drug FD therapy	Active Comparator		Drug: PPIs and/or Domperidone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Visceral Manipulation	Procedure	Usual FD drug therapy (PPIs and/or Domperidone in base of symptom complain) for 4 weeks and 4 VM visits with weekly frequency with first VM visit at day 1 of drug therapy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
FD symptoms: Bothersome postprandial fullness / Early satiation / Epigastric pain / Epigastric burning		baseline, 1, 4 and 8 weeks after therapy start

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Functional Dyspepsia

Exclusion Criteria:

Diabetes Mellitus
Mental disturbance
Thyroid gland dysfunction
Intestinal, liver and biliary tract disease
Concurrent medications that could interact with GI function
Positive Helicobacter Pylori status

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Massimo Rossi, DO B.Sc (Student)	Contact	00393929517349		massimo@rossimassimo.com

Overall Officials

Name	Affiliation	Role
Rossi Massimo, DO B.Sc (student)	International College of Osteopathic Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ambulatori Comunali di Cavenago Brianza	Recruiting	Cavenago di Brianza	Milano	20040	Italy