A multicentre, double-blind, randomised, active- and placebo-controlled clinical trial on the pain relieving effects of the modfied-release formulation of flupirtine in patients suffering from moderate to severe chronic low back pai

• Conditions: chronic low back pain; MedDRA version: 12.0Level: LLTClassification code 10024891Term: Low back pain

• Registration Number: EUCTR2009-013268-38-DE
• Lead Sponsor: AWD.pharma GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-24
• Last Update Posted: 20 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria
•male or female patients, aged 18 to 75 (inclusive)
•chronic low back pain (>12 weeks)
•pretreatment with either NSAIDs, cox-2 inhibitors, dipyrone or paracetamol as recommended by national LBP treatment guidelines
•mild to moderate stage of pain chronification (stage I or II) according to the Mainz Pain Staging System (MPSS).
•an average pain intensity classified as moderate to severe pain intensity at baseline (i.e. at least 4” on the NRS-11 or at least moderate” on the VRS-5).
•significant worsening of pain intensity after discontinuation of the pre-study medication with a deterioration of both, the lowest and average low back pain intensity index (LBPI) of at least 1 point on the NRS-11 and one point on the 5-point patient global assessment of response to therapy (PGART) scale
•women of childbearing potential must use a reliable method of contraception
•patient must give written informed consent, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria
Lack of suitability for the trial
•a rating of the patient global assessment of disease status (PGADS) as very poor
•no significant worsening of the LBPI after discontinuation of the pre-study medication
•back pain caused by any spinal fracture (e.g. osteoporotic crush).
•history of any surgery in the back.
•clinical and radiological evidence of Bechterew’s or Paget’s disease.
•clinical signs for acute nerve root lesion (hyporeflexia, weakness, dermatomal sensory deficite).
•acute back pain caused by soft tissue damage.
•malignant diseases with involvement of the spinal column.
•metabolic bone diseases.
•chronic inflammatory diseases of the spinal column due to Psoriasis arthritis, Reiter syndrome, arthritides in connection with enteropathies (Colitis ulcerosa, M. Crohn).
•necessity for simultaneous administration of not permitted medication during the study (incl. topical preparations applied to the pain area, local injections).
•necessity of other concomitant, pain relieving therapy measures during the study.
•concomitant disease: clinically significant abnormalities on pre-examination, vital signs, ECG or laboratory tests.
•pain-free states during daytime during the screening period (as stated in the patient diary).
•tailored treatment targets of 0” or 1” at baseline (NRS-11).
•hepatic impairment and increased liver enzymes (GOT, GPT and GGT, ? twice the upper reference range).
•neurological or psychiatric disease or drug or alcohol abuse which would interfere with the subjects proper completion of the study.

Study & Design

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