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SMILE: Pilot Trial to Assess the Feasibility of Implementing Objective Parameters in Patients Affected by Knee Osteoarthritis

Sponsor
River Pharma S.r.l. (Other)
Overall Status
Completed
CT.gov ID
NCT03421054
Collaborator
Opera CRO, a TIGERMED Group Company (Other)
8
Enrollment
1
Location
1
Arm
1.8
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pilot, open non-controlled trial to assess the feasibility of implementing objective parameters as primary endpoints in a clinical trial with patients affected by knee osteoarthritis.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: patients assuming nutraceutical containing HA
 N/A

Detailed Description

• 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 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 range 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 :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot, Open Non-controled Trial to Assess the Feasibility of Implementing Objective Parameters as Primary Endpoints in a Clinical Trial With Patients Affected by Knee Osteoarthritis
Actual Study Start Date :
Mar 19, 2018
Actual Primary Completion Date :
Apr 15, 2018
Actual Study Completion Date :
May 14, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: nutraceutical containing HA

pain reduction of the affected knee in the patients assuming nutraceutical containing HA

Dietary Supplement: patients assuming nutraceutical containing HA
pain reduction of the affected knee in the patients assuming nutraceutical containing HA

Outcome Measures

Primary Outcome Measures

  1. synovial effusion reduction [week 4 and 8]

    Correlation between reduction in VAS (at rest) and ultrasonography parameters

Secondary Outcome Measures

  1. pain reduction [week 4 and 8]

    Correlation between reduction in VAS (at rest; on moving; on pressing) and Actigraphy parameters.

Eligibility Criteria

Criteria

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

  • Any gender and age from 50 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 (1). 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 (2).

  • 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; 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.
  • Opera CRO, a TIGERMED Group Company

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:
NCT03421054
Other Study ID Numbers:
  • Pilot OPRPH/0117/FS
First Posted:
Feb 5, 2018
Last Update Posted:
Oct 1, 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 1, 2019