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SMILE: Clinical Trial to Evaluate the Effects of a Nutraceutical in Patients Affected by Knee Osteoarthritis

Sponsor
River Pharma S.r.l. (Other)
Overall Status
Completed
CT.gov ID
NCT03612986
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
11.1
Actual Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Double blind, placebo controlled trial to evaluate the effects of a nutraceutical containing high-molecular-weight hyaluronic acid (HA) and acetyl-11-keto-beta-boswellicacid (AKBA) in patients affected by knee osteoarthritis.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: SYALOX® 300 Plus
  • Dietary Supplement: Placebo
 N/A

Detailed Description

The primary objective of the trial is to assess the feasibility of implementing Ultrasonography and Range of Motion (ROM) as objective measurements to correlate the improvement of the knee mobility with the pain reduction of the affected knee in the patients assuming nutraceutical containing hyaluronic acid (HA).

The secondary objectives of the trial are:

  • to assess the feasibility of implementing Actigraphy as objective measurements to correlate the improvement of the knee mobility with the pain reduction (optional).

  • to evaluate the enrollment rate in one month.

The explorative objectives of the trial are:

• Preliminary data on efficacy of the tested product.

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Double Blind, Placebo Controlled Trial to Evaluate the Effects of a Nutraceutical Containing High-Molecular-Weight Hyaluronic Acid (HA) and Acetyl-11-Keto-Beta-Boswellic Acid (AKBA) in Patients Affected by Knee Osteoarthritis
Actual Study Start Date :
Aug 22, 2018
Actual Primary Completion Date :
Apr 10, 2019
Actual Study Completion Date :
Jul 26, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A: Active comparator SYALOX® 300 Plus

Active Nutraceutical containing HA and AKBA (SYALOX® 300 Plus) 1 tablet/day, oral administration

Dietary Supplement: SYALOX® 300 Plus
Reduction of pain and improvement of the knee mobility in patients affected by knee osteoarthritis
Placebo Comparator: B: Placebo

Placebo 1 tablet/day, oral administration

Dietary Supplement: Placebo
Placebo comparator. No chemical effect expected

Outcome Measures

Primary Outcome Measures

  1. Visual Analogue Scale (VAS) results at rest. Change is being assessed. [week 0, 4 and 16]

    Change in Visual Analogue Scale (VAS) results at rest, measured in mm

  2. Knee Range of Motion (ROM) results measured by goniometer. Change is being assessed. [week 0, 4 and 16]

    Change in Range of Motion (ROM) results, measured in grades by goniometer.

Secondary Outcome Measures

  1. Visual Analogue Scale (VAS) results at moving. Change is being assessed. [week 0, 4 and 16]

    Change in Visual Analogue Scale (VAS) results at moving, measured in mm

  2. Visual Analogue Scale (VAS) results on pressing. Change is being assessed. [week 0, 4 and 16]

    Change in Visual Analogue Scale (VAS) results at pressing, measured in mm

  3. Ultrasonography parameters results. Change is being assessed. [week 0 and 16]

    Change of presence or absence of Synovial fluid, Articular cartilage damage, Medial meniscal protrusion, Lateral meniscal protrusion, Medial osteophytes, Lateral osteophytes, Enthesopathies, Effusion is being assessed.

  4. Knee injury and Osteoarthritis Outcome Score (KOOS). Change is being assessed. [week 0, 4 and 16]

    Change in parameters of quality of life will be assessed through Knee injury and Osteoarthritis Outcome Score (KOOS).

  5. Index of Severity for Osteoarthritis of the Knee by Lequesne et al. Change is being assessed. [week 0, 4 and 16]

    Change in parameters of quality of life will be assessed through Index of Severity for Osteoarthritis of the Knee by Lequesne et al.

  6. Knee movement results using an actimeter (accelerometer). Change is being assessed. [week 0 and 16]

    Knee movement based on acceleration results using an actimeter, device based on an accelerometer. The results will be measured in meter/second squared (m/s2) Change is being assessed.

Other Outcome Measures

  1. Safety outcomes assessed by number of adverse events (AE)/serious adverse events (SAE) [day 0, week 4 and 16]

    Adverse events (AE)/serious adverse events (SAE) (number of events occured, related to the investigational product administration)

  2. Safety assessment based on rescue medication (Paracetamol 500mg) administration [day 0, week 4 and 16]

    Safety assessed by the number of rescue medication tablets administered daily.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Any gender and age from 45 to 70 years

  • Symptomatic osteoarthritis (OA) of the knee with mild joint discomfort for at least 6 months prior to enrollment, following ACR criteria with history and physical examination(44). Subjects diagnosed with bilateral knee OA will be asked to specify the most affected knee at baseline, and this knee will be evaluated throughout the study period.

  • Available confirmatory X-ray (performed within the previous 6 months) diagnosis (Kellgren/Lawrence score 2) at the evaluated knee joint(45).

  • Subjects experienced pain for at least 15 of the 30 days prior to the start of the study.

Exclusion Criteria:

  • Subjects who have any inflammatory arthritic condition (different from the OA of the knee), fibromyalgia, multiple sclerosis or autoimmune disorder.

  • Treatment with oral corticosteroids within 4 weeks before screening.

  • Intra-articular injections of HA or corticosteroids in the target joint within 3 months before screening.

  • Treatment with anti-inflammatory or chondroprotective drugs (chondroitin sulfate, glucosamine, methylsulfonylmethane, HA, diacerein) 2 weeks before the selection.

  • HA-containing nutritional supplements or cosmetics during the month before the study.

  • Previous surgical treatment of knee joint(s) or its necessity necessity for osteoarthritis (high tibial osteotomy, arthroplasty); complication(s) necessary for hospitalization and surgical treatment.

  • Significant injury to the target joint within the past 6 months prior to screening (identified from medical history).

  • Subjects following an energy-restricted diet for weight loss.

  • Pregnant women, nursing mothers, or women (only if childbearing potential) not using adequate methods of contraception.

  • Subjects with cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.

  • Participation in an interventional clinical study in the previous 30 days.

  • Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Opera Contract Research Organization S.r.l. Timişoara Timis Romania 300209

Sponsors and Collaborators

  • River Pharma S.r.l.

Investigators

  • Principal Investigator: Bogdan Andor, MD, MEDICALI'S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
River Pharma S.r.l.
ClinicalTrials.gov Identifier:
NCT03612986
Other Study ID Numbers:
  • OPRPH/0118/FS
First Posted:
Aug 2, 2018
Last Update Posted:
Oct 2, 2019
Last Verified:
Sep 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee

Study Results

No Results Posted as of Oct 2, 2019