Assessment of Tapentadol effects on patients with pain central sensitization using functional MRI

Phase 1

Active, not recruiting

• Conditions: Patients suffering from pain due to knee osteoarthritis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-005082-31-ES
• Lead Sponsor: MRI Research Unit, Radiology Department. Hospital del Mar.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-04
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.A diagnosis of knee OA and suitable for the study as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
2.Have a radiological and clinical diagnosis of knee OA based upon American College of Rheumatology (ACR) criteria (1986) affecting at least one knee of a minimum of 3 months in symptom duration prior to screening.
3.Central sensitization as defined by a positive clinical evidence of pain central sensitization affecting the knee combined with a minimum of 2 tender points around the affected knee experimentally verified using pain thresholds (Arendt-Nielsen et al. 2010, Graven-Nielsen et al. 2010, Woolf 2011, Imamura et al. 2008, Nijs et al. 2010).
4.Patients with Brief Pain Inventory (BPI) item 5 score of 6-10 points
5.Subject is either male or female and at least 45 years of age.
6.Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
7.Patients capable to be treated according to the technical specifications of summary of product characteristics (SmPC).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

1.A female subject is eligible to participate if she is of non-childbearing potential.
2.Body weight >120kg.
3.Severe or non-stable medical conditions.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified