NCT01203670

Brief Summary

The aim of the study is to evaluate renal and digestive tolerance of a food supplement, phytalgic, on elderly volunteers.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
Last Updated

September 22, 2010

Status Verified

September 1, 2010

First QC Date

September 15, 2010

Last Update Submit

September 21, 2010

Conditions

Renal ToleranceDigestive Tolerance

Keywords

Glomerular filtration rate (GFR)Aspartate Amino Transferase (ASAT)Alanine Amino transferase (ALAT)gamma Glutamyl transpeptidase (gamma GT)LipaseAmylase

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Quality of life determined by Western Ontario and McMaster universities (WOMAC)Visual Analogue Scale(VAS)

    168 days

Study Arms (1)

Soft capsules of Phytalgic

EXPERIMENTAL

Phytalgic is a food supplement. Its galenic form is soft capsule.

Dietary Supplement: Phytalgic

Interventions

PhytalgicDIETARY_SUPPLEMENT

Volunteers have to take three soft capsules per day, one in the morning and two in the evening.

Soft capsules of Phytalgic

Eligibility Criteria

Age70 Years - 87 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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
  • ASAT : Men \< 150 UI/L - Women \< 100 UI/L
  • ALAT : Men \< 180 UI/l - Women \< 130 UI:l
  • Gamma GT Men \< 180 UI/l - Gamma GT Women \< 100 UI/l
  • Amylase \< 250 UI/l
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département de Pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - CHU de Bordeaux

Bordeaux, 33076, France

Location

Study Officials

  • Alain JACQUET, MD

    Département de pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - Centre Hospitalo-Universitaire de Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 16, 2010

Study Completion

December 1, 2009

Last Updated

September 22, 2010

Record last verified: 2010-09

Locations

FR(1)