Renal and Digestive Tolerance of a Food Supplement, Phyta... | NCT01203670

Studies
Renal and Digestive Tolerance of a Food Supplement, Phytalgic, in Elderly Volunteers - A Multicentric Open Trial

NCT01203670

Sponsor

Phythea

Status

Completed

Last Update Posted

Sep 22, 2010Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Renal Tolerance
Digestive Tolerance

Interventions

Phytalgic

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

Status Module

Record Verification Date

Sep 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

Not provided

Primary Completion Date

Not provided

Completion Date

Dec 2009Actual

First Submitted Date

Sep 15, 2010

First Submission Date that Met QC Criteria

Sep 15, 2010

First Posted Date

Sep 16, 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

Sep 21, 2010

Last Update Posted Date

Sep 22, 2010Estimated

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

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Soft capsules of Phytalgic	Experimental	Phytalgic is a food supplement. Its galenic form is soft capsule.	Dietary Supplement: Phytalgic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phytalgic	Dietary Supplement	Volunteers have to take three soft capsules per day, one in the morning and two in the evening.	Soft capsules of Phytalgic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Renal tolerance by Glomerular filtration rate (GFR) determination; Digestive tolerance by Aspartate Amino transferase (ASAT), Alanine Amino Transferase (ALAT), gamma Glutamyl Transpeptidase (gamma GT), lipase and amylase determination		168 days

Secondary Outcomes

Measure	Description	Time Frame
Quality of life determined by Western Ontario and McMaster universities (WOMAC)Visual Analogue Scale(VAS)		168 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

70 years old minimum
Satisfying general health judged by principal investigator
Pain and /or stifness associated with arthritis
Regular used of analgesics and/or non-steroidal anti-inflammatory drugs (NSAIDs)
Digestive tolerance biomarkers
1. ASAT : Men < 150 UI/L - Women < 100 UI/L
2. ALAT : Men < 180 UI/l - Women < 130 UI:l
3. Gamma GT Men < 180 UI/l - Gamma GT Women < 100 UI/l
4. Amylase < 250 UI/l
5. Lipase < 750 UI/l
Renal tolerance biomarker: Glomerular filtration rate (GFR)superior or equal to 60 mL /min / 1.73m3 - calculated with the "Modification of the Diet in Renal Diseases" formula

Exclusion Criteria:

Inflammatory arthritis
Allergy to any constituents of the study drug
Types 2 diabetes
Not legally fit to participate
Any treatment able to modify determined biological parameters

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

87 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alain JACQUET, MD	Département de pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - Centre Hospitalo-Universitaire de Bordeaux	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Département de Pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - CHU de Bordeaux		Bordeaux		33076	France