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Trial record 1 of 1 for:    NCT01725087
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Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01725087
Recruitment Status : Completed
First Posted : November 12, 2012
Last Update Posted : July 15, 2021
Forest Laboratories
Information provided by (Responsible Party):
Tris Pharma, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Low Back Pain Drug: Matching Placebo Drug: Low Dose GRT6005 Drug: Medium Dose GRT6005 Drug: High Dose GRT6005 Drug: Tapentadol Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1089 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy, Safety, and Tolerability of GRT6005 in Subjects With Moderate to Severe Chronic Low Back Pain.
Study Start Date : November 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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) ]
  2. 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01725087

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Sponsors and Collaborators
Tris Pharma, Inc.
Forest Laboratories
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Study Chair: Study Director Grünenthal GmbH
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Responsible Party: Tris Pharma, Inc. Identifier: NCT01725087    
Other Study ID Numbers: KF6005/06
2012-001920-36 ( EudraCT Number )
First Posted: November 12, 2012    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents