Effect of treatment with the painkiller tapentadol on pain in patients with fibromyalgia

• Conditions: Fibromyalgia; MedDRA version: 18.1Level: PTClassification code 10048439Term: FibromyalgiaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 18.1Level: LLTClassification code 10016631Term: Fibromyalgia syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-005258-37-NL
• Lead Sponsor: MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-17
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Age: 18 – 75 years.
- Sex: Either sex.
- American Society of Anesthesiologists class 1 and 2 patients, 18 – 75 years; BMI < 40 kg/m2, and ability to give informed consent.
Additionally patients need to have a pain score = 5 (on a scale of 0-10) for most of the day and meet the 2010 American College of Rheumatology diagnostic criteria. These criteria include a widespread pain index (WPI; 0-18 points), which defines the number of body areas in which a patient experienced pain during the last week, and a symptom severity score (SS-score; 0-12 points), which indicates the level of other core symptoms of fibromyalgia such as fatigue, un-refreshing sleep and cognitive symptoms. Inclusion criteria are:
(1) a WPI = 7 with an SS-score = 5
or
(2) a WPI of 3-6 with an SS-score = 9.
Finally, patients need to have an absent/inactive CPM response.
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Unable to give written informed consent; medical disease such as pulmonary, renal, liver, cardiac, gastro-intestinal, vascular disease; (iii) allergy to study medication; (iv) history of illicit drug abuse or alcohol abuse; (v) history of psychosis; (vi) epilepsy; (vii) pregnancy and/or lactation; (viii) strong opioids and benzodiazepine use.

Study & Design

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