Investigation of Kritech Efficacy on Subjects Having Functional Discomfort Associated to Joints and Muscles Disorders

NCT02318875 | Completed Phase 3

• 1 other identifier: 2011-A00320-41/1
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

Joints and muscles disorders are common symptoms in the population. They are characterized by swelling, pain, functional impairment and morning stiffness. These disorders can be really disabling and painful, affecting the person's quality life. The purpose of this clinical trial is to test Kritech (Krill oil) efficacy in reducing these symptoms in 154 subjects complaining functional discomfort associated to joints and muscles disorders.

Conditions

Pain

Keywords

Inflammation; swell; pain; functional impairment; stiffness

Outcome Measures

Primary Outcomes (1)

• SMFA score

  12 weeks

Secondary Outcomes (5)

• SMFA " dysfunction index " and " bother index " subscores

  12 weeks

• MCS (Mental Composite Score) and PCS (Physical Composite Score) of SF-36® questionnaire

  12 weeks

• Pain evaluated by EVA (Échelle Visuelle Analogique)

  12 weeks

• Clinical Global Impression (CGI scale)

  12 weeks

• Analgesics consumption

  12 weeks

Study Arms (2)

Kritech group

EXPERIMENTAL

Subjects take 1 Kritech capsule per day (dose of 300mg)

Dietary Supplement: Kritech administration

Placebo group

PLACEBO COMPARATOR

Subjects take 1 placebo capsule per day

Other: Placebo adminstration

Interventions

Kritech administration DIETARY_SUPPLEMENT

300mg/day (1 capsule) during 12 weeks; oral ingestion

Kritech group

Placebo adminstration OTHER

1 placebo capsule per day during 12 weeks; oral ingestion

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects;
• \>18 years old;
• Complaining functional discomfort associated to joints and/or muscles disorders, motility disorders and/or initial SMFA score higher or equal to 15 ;
• Able to give a written or verbal informed consent,
• Affiliated or beneficiary of social security

You may not qualify if:

• IMC\>30kg/m
• Acute or chronic, progressive joint disorders (arthrosis, rheumatoid arthritis, acute articular rheumatism) of first or second degree and correlated treatments;
• Subjects refusing of giving their written or verbal informed consent
• Subjects deprived of freedom following an administrative or judicial decision
• Participation to another clinical trial in the last four weeks;

Sponsors & Collaborators

• Vivatech: lead

Study Sites (1)

Plateforme de Recherche Clinique - CIC1401- Plurithématique Tripode 13A3 Hôpital PELLEGRIN

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Pain; Inflammation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Nicholas Moore, Professor

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 17, 2014
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 17, 2014

Record last verified: 2014-12

Locations

FR (1)