Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain.
This study is currently recruiting participants.
Verified June 2013 by Grünenthal GmbH
Sponsor:
Grünenthal GmbH
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Grünenthal GmbH
ClinicalTrials.gov Identifier:
NCT01725087
First received: November 8, 2012
Last updated: June 7, 2013
Last verified: June 2013
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Purpose
The purpose of this trial is to evaluate the safety and efficacy of once daily orally administered GRT6005 in a total of 3 fixed doses compared to placebo in subjects with moderate to severe chronic Low Back Pain (LBP). The study includes a maximum of 21 days screening period followed by a 2-week titration period and 12-week maintenance double-blind treatment period and a 10-14 day safety follow up period. Patients who are eligible for the double-blind treatment period will be randomized to one of the following treatment groups: GRT6005 low-dose, GRT6005 medium dose, GRT6005 high-dose, Tapentadol or placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Low Back Pain |
Drug: Matching Placebo Drug: Low Dose GRT6005 Drug: Medium Dose GRT6005 Drug: High Dose GRT6005 Drug: Tapentadol |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy, Safety, and Tolerability of GRT6005 in Subjects With Moderate to Severe Chronic Low Back Pain. |
Resource links provided by NLM:
Further study details as provided by Grünenthal GmbH:
Primary Outcome Measures:
- European Union: the change from baseline pain to the weekly average 24-hour pain during the entire 12 weeks of the maintenance phase of the double-blind Treatment Period. [ Time Frame: Baseline to End of Treatment (Week 14) ] [ Designated as safety issue: No ]
- United States: the change from baseline pain to the average 24-hour pain during Week 12 of the maintenance phase. [ Time Frame: Baseline to End of Treatment (Week 14) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Matching Placebo
Twice daily oral administration of matching placebo for 14 weeks
|
Drug: Matching Placebo |
|
Experimental: Low Dose GRT6005
Once daily GRT6005 low dose oral administration for 12 weeks with a titration period of 2 weeks.
|
Drug: Low Dose GRT6005 |
|
Experimental: Medium Dose GRT6005
Once daily GRT6005 medium dose oral administration for 12 weeks with a titration period of 2 weeks.
|
Drug: Medium Dose GRT6005 |
|
Experimental: High Dose GRT6005
Once daily GRT6005 high dose oral administration for 12 weeks with a titration period of 2 weeks.
|
Drug: High Dose GRT6005 |
|
Active Comparator: Tapentadol
Twice daily oral administration of Tapentadol for 12 weeks with a titration period of 2 weeks.
|
Drug: Tapentadol |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Chronic Low Back Pain of non-malignant origin and present for at least 3 months.
- Signed informed consent.
- Pain intensity score of 5 or greater on the 11-point numeric rating scale (where 0 indicates "no pain" and 10 indicates "as bad as you can imagine").
- On stable analgesic medications (non-opioid and/or opioid medications) for chronic low back pain with regular intake for at least 3 months and dissatisfied with current analgesic treatment.
Exclusion Criteria:
- Female subjects who are pregnant or are breastfeeding.
- Presence of risk factors for Torsade de Pointes.
- Any clinically significant disease or laboratory findings that may affect efficacy or safety assessments or may compromise the safety during trial participation, e.g., significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, metabolic, neurological, or psychiatric disorders.
- History of acute hepatitis within the past 3 months or chronic hepatitis or a positive result on anti-hepatitis A antibody, hepatitis B surface antigen, or anti-hepatitis C antibody. History of human immunodeficiency virus (HIV) infection.
- History of seizure disorder.
- Chronic low back pain potentially associated with a specific spinal cause.
- Surgery or painful procedure during or within 3 months of enrollment.
- Conditions that contribute and confound the assessment of pain.
- Subjects with impaired renal function.
- Subjects with impaired hepatic functionality.
- Neuromodulation.
- Cancer.
- Clinically relevant history of hypersensitivity, allergy or contraindications to any of the Investigational Medicinal Products' excipients, paracetamol/acetaminophen, tapentadol Hydrochloride, or opioid analgesics (or excipients).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725087
Show 62 Study Locations
Contacts
| Contact: René Allard | +49 241 569 3223 | clinical-trials@grunenthal.com |
Show 62 Study LocationsSponsors and Collaborators
Grünenthal GmbH
Forest Laboratories
Investigators
| Study Chair: | Study Director | Grünenthal GmbH |
More Information
No publications provided
| Responsible Party: | Grünenthal GmbH |
| ClinicalTrials.gov Identifier: | NCT01725087 History of Changes |
| Other Study ID Numbers: | KF6005/06, 2012‐001920‐36 |
| Study First Received: | November 8, 2012 |
| Last Updated: | June 7, 2013 |
| Health Authority: | Denmark: Danish Health and Medicines Authority Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Austria: Agency for Health and Food Safety Belgium: Federal Agency for Medicinal Products and Health Products Germany: Federal Institute for Drugs and Medical Devices Spain: Spanish Agency of Medicines Hungary: National Institute of Pharmacy United Kingdom: Medicines and Healthcare Products Regulatory Agency Sweden: Medical Products Agency Finland: Finnish Medicines Agency |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013