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Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Grünenthal GmbH
ClinicalTrials.gov Identifier:
NCT01347671
First received: May 2, 2011
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.


Condition Intervention Phase
Pain
Diabetic Neuropathies
 Drug: GRT6005
Drug: Matching Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized 4-week Phase IIa Trial Evaluating the Efficacy, Safety, and Tolerability of GRT6005, a New Centrally Acting Analgesic, in Subjects With Pain Due to Diabetic Polyneuropathy.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Grünenthal GmbH:

Primary Outcome Measures:
  • Change in mean daily pain intensity score [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]

    Participants will be selected based on their medical history and clinical examination.

    Efficacy of the treatment (i.e., reduction of pain) will be evaluated with the 11-point numeric rating scale (NRS), where 0 represents no pain and 10 represents "pain as bad as you can imagine".



Secondary Outcome Measures:
  • Response measured in percentage change of pain intensity from baseline [ Time Frame: End of 4 Weeks ] [ Designated as safety issue: No ]
  • Changes in Quantitative Sensory Testing from baseline [ Time Frame: Baseline, week 1 and week 4 ] [ Designated as safety issue: No ]
  • Neuropathic Pain Scale, changes from baseline [ Time Frame: End of 4 weeks ] [ Designated as safety issue: No ]
  • Short Form of the Brief Pain Inventory, changes from baseline [ Time Frame: End of 4 weeks ] [ Designated as safety issue: No ]
  • Leeds Sleep Evaluation Questionnaire [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • Quality of Life Index -Short-Form-12®, from baseline [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • Patient's Global Impression of Change [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • Quality of Life EuroQoL-5 Dimension score, change from baseline [ Time Frame: End of 4 weeks ] [ Designated as safety issue: No ]
  • Rescue medication use [ Time Frame: End of 4 weeks ] [ Designated as safety issue: No ]
  • Clinical Opioid Withdrawal Scale [ Time Frame: End of 4 weeks ] [ Designated as safety issue: Yes ]
  • Plasma concentration [ Time Frame: End of 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 189
Study Start Date: May 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 25 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 25 µg GRT6005 per day
 Drug: GRT6005
25µg/day once daily
Active Comparator: 75 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 75 µg GRT6005 per day
 Drug: GRT6005
75 µg/day once daily
Active Comparator: 200 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 200 µg GRT6005 per day
 Drug: GRT6005
200 µg/day once daily
Placebo Comparator: Matching Placebo
Participants allocated to this treatment arm will receive a dose of matched placebo once a day.
 Drug: Matching Placebo
Once daily

  Eligibility

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

Inclusion Criteria:

  • Men and women, 18 to 75 years old.
  • Type 1 or type 2 diabetes.
  • Painful DPN symptoms and signs for at least 3 months.
  • Blood glucose controlled with medication.
  • Glycosylated hemoglobin not greater than 9.5 or 11%, country dependent.
  • Prior analgesic medication.
  • Average score of 4 or greater on the 11 point NRS during the last 3 days prior to randomization.

Exclusion Criteria:

  • Impaired liver, cardiac or renal function.
  • Breastfeeding and pregnancy.
  • History of substance abuse, alcohol or medication.
  • Chronic gastrointestinal disease.
  • History of seizures and or epilepsy.
  • History or presence of malignancy.
  • Presence of painful medical conditions that are not due to diabetic neuropathy, e.g. rheumatoid arthritis.
  • Allergies to opioids, acetaminophen or excipients of the medications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347671

Locations
Bulgaria
Site 4502
Sofia, Bulgaria, 1431
Germany
Site 4112
Aschaffenburg, Germany, 63739
Site 4109
Bad Oeynhausen, Germany, 32545
Site 4110
Berlin, Germany, 13125
Site 4101
Berlin, Germany, 10117
Site 4111
Dresden, Germany, 01307
Site 4107
Hamburg, Germany, 20253
Site 4117
Hamburg, Germany, 22587
Site 4104
Hannover, Germany, 30167
Site 4108
Hannover, Germany, 30159
Site 4115
Heidelberg, Germany, 69120
Site 4106
Kiel, Germany, 24119
Site 4102
Lübeck, Germany, 23562
4103
Mainz, Germany, 55116
Site 4105
Münster, Germany, 48145
Site 4113
Schwerin, Germany, 19055
Site 4116
Wangen, Germany, 88239
Romania
Site 4405
Bucuresti, Romania, 010496
Site 4402
Bucuresti, Romania, 011025
Site 4407
Sibiu, Romania, 550166
Site 4401
Tg. Mures, Romania, 540139
Site 4406
Timisoara, Romania, 300594
Sponsors and Collaborators
Grünenthal GmbH
Forest Laboratories
Investigators
Principal Investigator: Thomas Forst, Prof. Dr. ikfe GmbH, Institut for Klinische Forschung und Entwicklung, Parcusstr. 8, 55116 Mainz, Germany
  More Information

No publications provided

Responsible Party: Grünenthal GmbH
ClinicalTrials.gov Identifier: NCT01347671     History of Changes
Other Study ID Numbers: 430409, 2010-022557-42
Study First Received: May 2, 2011
Last Updated: June 5, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Grünenthal GmbH:
analgesia
analgesics
pain
chronic pain
neuropathic pain

Additional relevant MeSH terms:
Diabetic Neuropathies
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013