Renal ToleranceNCT01203670
Renal and Digestive Tolerance of a Food Supplement, Phytalgic, in Elderly Volunteers - A Multicentric Open Trial
A study testing Phytalgic in people with Renal Tolerance and Digestive Tolerance, run by Phythea at 1 site in France.
Trial summary
The aim of the study is to evaluate renal and digestive tolerance of a food supplement, phytalgic, on elderly volunteers. Read more about this study
- Who is it for?
- Ages 70 to 87 years
- Conditions the study is for
- Renal Tolerance, Digestive Tolerance
- What is being tested?
- Phytalgic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 87 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
- ASAT : Men < 150 UI/L - Women < 100 UI/L
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Département de Pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - CHU de Bordeaux
Bordeaux, 33076
About this study
The aim of the study is to evaluate renal and digestive tolerance of a food supplement, phytalgic, on elderly volunteers.
- Conditions
- Renal Tolerance, Digestive Tolerance
- Being tested
- Phytalgic
- Keywords
- Glomerular filtration rate (GFR), Aspartate Amino Transferase (ASAT), Alanine Amino transferase (ALAT), gamma Glutamyl transpeptidase (gamma GT), Lipase, Amylase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhytalgicDietary supplement
Volunteers have to take three soft capsules per day, one in the morning and two in the evening.
| Study group | Role | What they receive |
|---|---|---|
| Soft capsules of Phytalgic | Experimental | Phytalgic is a food supplement. Its galenic form is soft capsule. Receives: Dietary Supplement: Phytalgic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 168 days
Secondary outcomes (1)
Quality of life determined by Western Ontario and McMaster universities (WOMAC)Visual Analogue Scale(VAS)
Measured: 168 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phythea
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alain JACQUET, MD, Principal investigator, Département de pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - Centre Hospitalo-Universitaire de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203670
- Sponsor's protocol ID
- PHYTHEA-e437-950
- Status last verified
- Sep 2010
- First submitted
- 15 Sep 2010
- Last updated
- 22 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal and Digestive Tolerance of a Food Supplement, Phytalgic, in Elderly Volunteers - A Multicentric Open Trial
- ClinicalTrials.gov ID
- NCT01203670
- Acronym / sponsor ID
- PHYTHEA-e437-950
- Conditions
- Renal Tolerance, Digestive Tolerance
- Keywords
- Glomerular filtration rate (GFR), Aspartate Amino Transferase (ASAT), Alanine Amino transferase (ALAT), gamma Glutamyl transpeptidase (gamma GT), Lipase, Amylase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- PhytheaIndustry (pharma, biotech, devices)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate renal and digestive tolerance of a food supplement, phytalgic, on elderly volunteers.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Soft capsules of Phytalgic | Experimental | Dietary Supplement: PhytalgicPhytalgic is a food supplement. Its galenic form is soft capsule. |
Who may qualify
- Ages
- 70 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhytalgicVolunteers have to take three soft capsules per day, one in the morning and two in the evening. | Dietary supplement | Soft capsules of Phytalgic |
Primary outcome
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
Time frame: 168 days
1 secondary outcome
Quality of life determined by Western Ontario and McMaster universities (WOMAC)Visual Analogue Scale(VAS)
Time frame: 168 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain JACQUET, MD principal investigator
Département de pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - Centre Hospitalo-Universitaire de Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phytalgic in people with Renal Tolerance and Digestive Tolerance, run by Phythea at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 168 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2010.