GRT6005 in subjects with Chronic low back pain

• Research type

  Research Study

• Full title

  Efficacy, safety and tolerability of GRT6005 in subjects with moderate to severe Chronic low back pain

• IRAS ID

  112774

• Contact name

  Richard Sawyer

• Sponsor organisation

  Grunenthal GmbH

• Eudract number

  2012-001920-36

• ISRCTN Number

  KF6005/06

• Research summary

  This Phase II trial includes participants with moderate to severe chronic Lower Back Pain (LBP). The aim of this study is to determine the efficacy, safety and tolerability of GRT6005 (study drug). Approximately 600 participants in Europe will be allocated equally but randomly to one of 5 arms. Participants in 3 of the arms will receive study drug and participant in the remaining 2 arms will receive Tapentadol or placebo. Paracetamol may be used as needed in addition to the study drug if the participant experiences strong back pain while taking part in the study. The planned number of participating sites is approximately 80 in 10 European countries, with 4 sites in the UK. The planned number of subjects per treatment arm is approximately 120, with a total recruitment of 600 participants. Each participant's expected to be in the trial for a maximum of 138 days, 24 days Enrollment Period, 100 days Treatment Period and 14 days Follow-up Period. The study will include both male and female participants, 18 years to 80 years of age with a documented clinical diagnosis of chronic LBP. Pain has to be of non-cancerous origin and with the participant experiencing this pain for at least 3 months. Participants must be on stable analgesic medications (non-opioid and/or opioid [drug dependent] medications) for their chronic LBP with regular intake (i.e., at least 4 days per week) for at least 3 months prior to the first visit for the study and must be dissatisfied with current pain treatment.

• REC name

  Wales REC 2

• REC reference

  12/WA/0316

• Date of REC Opinion

  4 Dec 2012

• REC opinion

  Further Information Favourable Opinion