Capsaicin Patches In Knee Osteoarthritis In Obese Patients

NCT03153813 | Terminated Phase 3

• 1 other identifier: CHILI-OB
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy and safety of high concentration capsaicin patches in pain due to osteoarthritis (OA) of the knee in patients with obesity

Conditions

Pain

Keywords

pain; knee osteoarthritis; obesity; capsaicin

Outcome Measures

Primary Outcomes (1)

• Effects on self reported average pain intensity on pain diaries throughout the study (on NRS from 0 to 10)

  The primary outcome measure will be the reduction of average pain intensity as assessed by the patients daily using a pain diary throughout the 3 months of the study. The comparison will be made with baseline pain values started 7 days before the treatment.

  Over the 3 months of the study

Secondary Outcomes (2)

• The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, function and stiffness

  at each follow up period 1, 2 and 3 months as compared to baseline values

• safety as assessed by side effects during and after application

  during and immeditaly after application and at each follow up period 1, 2 and 3 months

Study Arms (2)

Drug

EXPERIMENTAL

Up to 4 patches to cover a surface of 1200 cm2 will be applied to the painful area depending on the surface of pain during 60 minutes : capsaicin 8% patches (Qutenza)

Drug: capsaicin 8% patches (Qutenza)

Placebo

PLACEBO COMPARATOR

Up to 4 patches will be applied to the painful area depending on the surface of pain during 60 minutes : placebo

Other: Placebo patches

Interventions

capsaicin 8% patches (Qutenza) DRUG

Drug

Placebo patches OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled patients will be males or females,
• aged over 18 years,
• have pain for at least 3 months due to mild to moderate osteoarthritis of the knee (meeting American College of Rheumatology clinical and radiographic criteria), of at least moderate intensity (pain intensity score over the last 24 hours before enrolment ≥ 4/10),
• with a BMI above 30 kg/m²
• and no other pain conditions accounting for their disability.
• The skin will be intact and no blessed.
• All female patients should take contraception during all study and at least 30 days after closer.
• All patients must sign informed consent.
• All patients will be recruited from the Department of Nutrition, Ambroise Paré University Hospital and treatment will be given during a dedicated day care clinic.

You may not qualify if:

• Patients necessitating surgery,
• with relative contraindications to capsaicin patches, particularly with unstable hypertension or cardiac condition,
• past history of capsaicin use will not be included.

Sponsors & Collaborators

• Nadine ATTAL: lead

Study Sites (1)

Hospital Ambroise Paré, Nutrition Department

Boulogne-Billancourt, 92100, France

Location

MeSH Terms

Conditions

Pain; Osteoarthritis, Knee; Obesity

Interventions

Capsaicin; Transdermal Patch

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Equipment and Supplies

Study Officials

• Claire Carette

  Hospital Ambroise Pare Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-investigator

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: May 15, 2017
• Study Start: July 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

FR (1)