Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain.

Phase 2

Completed

• Conditions: Low Back Pain
• Interventions: Drug: High Dose GRT6005; Drug: Tapentadol; Drug: Low Dose GRT6005; Drug: Medium Dose GRT6005; Drug: Matching Placebo

• Registration Number: NCT01725087
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-08
• Study First Submitted QC: 2012-11-09
• Study First Posted: 2012-11-12
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1089

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose GRT6005	High Dose GRT6005	Once daily GRT6005 high dose oral administration for 12 weeks with a titration period of 2 weeks.
Tapentadol	Tapentadol	Twice daily oral administration of Tapentadol for 12 weeks with a titration period of 2 weeks.
Low Dose GRT6005	Low Dose GRT6005	Once daily GRT6005 low dose oral administration for 12 weeks with a titration period of 2 weeks.
Medium Dose GRT6005	Medium Dose GRT6005	Once daily GRT6005 medium dose oral administration for 12 weeks with a titration period of 2 weeks.
Matching Placebo	Matching Placebo	Twice daily oral administration of matching placebo for 14 weeks

Primary Outcome Measures

Name	Time	Method
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.	Baseline to End of Treatment (Week 14)
United States: the change from baseline pain to the average 24-hour pain during Week 12 of the maintenance phase.	Baseline to End of Treatment (Week 14)

Trial Locations

Locations (79)

AT003; 🇦🇹 Senftenberg, Austria

AT004; 🇦🇹 Wien, Austria

AT001; 🇦🇹 Wien, Austria

AT005; 🇦🇹 Wien, Austria

AT006; 🇦🇹 Wien, Austria

BE001; 🇧🇪 Bruxelles, Belgium

BE002; 🇧🇪 Edegem, Belgium

BE004; 🇧🇪 Genk, Belgium

DK004; 🇩🇰 Aalborg, Denmark

DK001; 🇩🇰 Frederiksberg, Denmark

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