Transdermal Delivery of Glucosamine to the Synovial Fluid of Male and Female With Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-18

Study Completion Date

2017-03-10

Brief Summary

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Glucosamine is commonly used as a treatment for Osteoarthritis (OA). While oral administration remains the most commonly used route, topical administration could offer numerous advantages such as targeted delivery to affected joints and overcoming the negative effects of the passage of the drug through the digestive system. The objective of this study is to assess the bioavailability of glucosamine in the synovial fluid of osteoarthritic joints, following the topical application of a commercially available transdermal glucosamine cream. Joint fluid samples will be collected from 2 groups of participants with knee OA: the Control group will not be subjected to any treatment while the Test group will apply 2g of transdermal glucosamine cream 1 to 3 hours before the joint fluid collection. Glucosamine concentration will be determined and the results obtained from both groups will be compared. This trial will potentially provide data to support that glucosamine can cross the skin and be delivered to the affected joint fluid when formulated in a transdermal cream base.

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Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Subjects who agreed to participate in the study could decide to be part of the Control group (no intervention) or the Test group (single dose, topical application of Transdermal Glucosamine Cream)

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

There is no possibility of subjective bias or placebo effect since the primary outcome is the drug concentration in the synovial fluid. Hence no blinding or randomization needed.

Study Groups

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Control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Test group

single dose (2g), topical application of Transdermal Glucosamine Cream (containing 10% w/w of glucosamine sulfate)

Group Type EXPERIMENTAL

Transdermal Glucosamine Cream

Intervention Type DRUG

Interventions

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Transdermal Glucosamine Cream

Intervention Type DRUG

Other Intervention Names

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TGC® Plus Capsaicin

Eligibility Criteria

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Inclusion Criteria

* Male and non-pregnant female human subjects
* 21 to 80 years old
* Subjects who need to undergo arthrocentesis (prescribed during prior medical assessment)
* Willingness to follow the protocol requirements

Exclusion Criteria

* Known allergy to shellfish
* Known history of hypersensitivity to Glucosamine or related drugs.
* Known history of hypersensitivity to Capsaicin (Capsicum extract)
* Known history of skin sensitivity
* Subjects who have taken any kind of glucosamine during the last 24 hours
* Subjects who have taken any kind of treatment for joint pain during the last 24 hours
* Subjects having scars/cut/dermatological abnormality at application site
* Pregnant or nursing women

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No