A Study to Assess the Safety and Efficacy of 7 Days Treatment With a Novel Analgesic in Subjects With Peripheral Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grünenthal GmbH
ClinicalTrials.gov Identifier:
NCT01485094
First received: October 5, 2011
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

The purpose of this trial is to determine whether a novel analgesic is effective in treating of neuropathic pain caused by herpetic infection, surgery, or trauma.


Condition Intervention Phase
Neuralgia
Drug: GRT6010
Drug: Pregabalin
Drug: Matching Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy, Tolerability, and Safety of 7 Days of Treatment With GRT6010 or Pregabalin in Comparison to Placebo in Subjects With Peripheral Neuropathic Pain.

Resource links provided by NLM:


Further study details as provided by Grünenthal GmbH:

Primary Outcome Measures:
  • Difference in ongoing pain intensity (Numeric Rating Scale) [ Time Frame: Baseline and day 7 (end of double blind treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in brush-evoked pain intensity. [ Time Frame: Baseline and day 7 (end of double blind treatment) ] [ Designated as safety issue: No ]
  • Difference for Dynamic Mechanical Allodynia and Mechanical Pain Sensitivity [ Time Frame: Baseline and day 7 (end of double blind treatment) ] [ Designated as safety issue: No ]
  • Assessment of responder rates [ Time Frame: Baseline and day 7 (end of double blind treatment) ] [ Designated as safety issue: No ]
  • Onset of curring pain relief [ Time Frame: Baseline and day 7 (end of double blind treatment) ] [ Designated as safety issue: No ]
  • Onset of ongoing pain relief [ Time Frame: Baseline and day 7 (end of double blind treatment) ] [ Designated as safety issue: No ]
  • Change in Neuropathic Pain Symptom Inventory scores [ Time Frame: Baseline and day 7 (end of double blind treatment) ] [ Designated as safety issue: No ]
  • Difference in Patient's Global Impression of Change [ Time Frame: Baseline and day 7 (end of double blind treatment) ] [ Designated as safety issue: No ]
  • Difference in Leeds Sleep evaluation questionnaire [ Time Frame: Baseline and day 7 (end of double blind treatment) ] [ Designated as safety issue: No ]
  • Change in area of static and dynamic allodynia [ Time Frame: Baseline and day 7 (end of double blind treatment) ] [ Designated as safety issue: No ]
  • Change in painDETECT scores [ Time Frame: Baseline and day 7 (end of double blind treatment) ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: December 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Matching placebo
Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
Drug: Matching Placebo

Matching Placebo capsules to the Pregabalin capsules and Matching Placebo oral solution to the GRT6010 solution.

Capsules twice daily on Days 1 to 7. Solution once daily.

Experimental: GRT6010
Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
Drug: GRT6010
Oral solution given once daily.
Active Comparator: Pregabalin
Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.
Drug: Pregabalin
Pregabalin capsules 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7.
Other Name: Lyrica®

Detailed Description:

This trial evaluates the effectiveness of a novel analgesic in peripheral neuropathic pain in a mixed patient population. Participants will be treated for one week and randomly assigned to the novel analgesic, pregabalin, or placebo. Pain will be characterized before and at the end of this period. This trial requires the participants to stay at the investigational site for 14 consecutive days.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years to 75 years
  • Presence of of persistent neuropathic pain for at least 6 months at the time of the Enrollment Visit. Allowed reasons for neuropathic pain are: modified radical mastectomy, breast conserving surgery, or cosmetic breast surgery. [Germany: subjects after cosmetic breast surgery may not be enrolled.]
  • Presence of "probable" or "definite" neuropathic pain.
  • Presence of dynamic mechanical allodynia on the affected side, or alternatively, the mechanical pain sensitivity for any of the pinprick stimuli is higher on the affected compared to the contralateral side.
  • At either Visit 5 or Visit 6: Presence of an average evoked pain intensity score of >20 on the 0 100 point numeric rating scale (NRS) for at least 1 of the 3 clinical sub-tests for dynamic mechanical allodynia (i.e., standardized brush, cotton wool tip or cotton wisp). The average will be calculated as the arithmetic mean of all measurements per sub test. Alternatively, the arithmetic mean of the 5 test replicates for any of the pinprick stimuli for mechanical pain sensitivity is at least 3 times higher for the affected side compared to the contralateral side.
  • Presence of an average ongoing pain intensity score of >4 to <9 on the 0-10 point numerical rating scale (NRS) without the use of rescue medication within the 3 day Baseline pain intensity evaluation Period with at least 7 of 9 assessments being present.
  • Dissatisfaction with the current treatment (i.e., lack of efficacy or intolerable side effects) if taking an opioid or non opioid analgesic medication for the painful neuropathy before enrollment.

Exclusion Criteria:

  • Any kind of hepatic impairment at Visit 1 or at Visit 3.
  • Either active hepatitis within the past 3 months or presence of chronic hepatitis irrespective of its activity status.
  • Estimated creatinine clearance of less than 60 mL/minute x 1.73 m2 at either Visit 1 or at Visit 3.
  • Clinically relevant cardiac disease (e.g., unstable angina pectoris, angina pectoris Canadian Cardiovascular Society [CCS] Grade III to IV, acute myocardial infarction within the last 3 months, cardiac insufficiency New York Heart Association [NYHA] Class III to IV).
  • Electrocardiogram (ECG) with clinically relevant findings at either Visit

    1 or at Visit 3, including but not limited to repeated prolongation of QTc > 450 ms (Fridericia correction), or a history of additional risk factors for torsade de pointes (e.g., family history of Long QT Syndrome).

  • Clinically relevant pulmonary disease (e.g., Medical Research Council breathlessness scale of 2 or above).
  • Specific antitumor therapy within the last 6 months, e.g., adjuvant radiotherapy or chemotherapy, biologics, or angiogenesis inhibitors.
  • CYP2D6 poor metabolizer phenotype as predicted by CYP2D6 genotyping.
  • Presence of confounding pain conditions (e.g., ulnar nerve entrapment, radial nerve injury associated with major soft-tissue or bone damage, cervico-thoracic radiculopathy, carpal tunnel syndrome, chemotherapy-induced peripheral neuropathy, or complex regional pain syndrome type I or type II).
  • Phantom breast or phantom limb pain.
  • Presence of exclusively negative symptoms of neuropathic pain (e.g., hypoesthesia or total anesthesia) in the affected area.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485094

Locations
Germany
DEU001
Mainz, Germany, D-55131
DEU002
Regensburg, Germany, 93053
Hungary
HUN004
Esztergom, Hungary, H-2500
HUN003
Győr, Hungary, H-9024
HUN001
Miskolc, Hungary, H-3526
HUN008
Szikszo, Hungary
United Kingdom
GBR001
Glasgow, United Kingdom
GBR002
Manchester, United Kingdom
Sponsors and Collaborators
Grünenthal GmbH
Investigators
Study Director: John Bothmer Grünenthal GmbH
  More Information

No publications provided

Responsible Party: Grünenthal GmbH
ClinicalTrials.gov Identifier: NCT01485094     History of Changes
Other Study ID Numbers: 967165, 2011-002092-42
Study First Received: October 5, 2011
Last Updated: January 17, 2013
Health Authority: Hungary: National Institute of Pharmacy
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Ministry of Health and Social Security

Keywords provided by Grünenthal GmbH:
neuralgia
postherpetic

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 17, 2014