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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

May 2, 2011
June 5, 2012
May 2011
January 2012   (final data collection date for primary outcome measure)
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".
Same as current
Complete list of historical versions of study NCT01347671 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy
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.

The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Pain
  • Diabetic Neuropathies
  • Drug: GRT6005
    25µg/day once daily
  • Drug: GRT6005
    75 µg/day once daily
  • Drug: GRT6005
    200 µg/day once daily
  • Drug: Matching Placebo
    Once daily
  • Active Comparator: 25 µg GRT6005
    Participants allocated to this treatment arm will receive a daily dose of 25 µg GRT6005 per day
    Intervention: Drug: GRT6005
  • Active Comparator: 75 µg GRT6005
    Participants allocated to this treatment arm will receive a daily dose of 75 µg GRT6005 per day
    Intervention: Drug: GRT6005
  • Active Comparator: 200 µg GRT6005
    Participants allocated to this treatment arm will receive a daily dose of 200 µg GRT6005 per day
    Intervention: Drug: GRT6005
  • Placebo Comparator: Matching Placebo
    Participants allocated to this treatment arm will receive a dose of matched placebo once a day.
    Intervention: Drug: Matching Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
189
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Germany,   Romania
 
NCT01347671
430409, 2010-022557-42
No
Grünenthal GmbH
Grünenthal GmbH
Forest Laboratories
Principal Investigator: Thomas Forst, Prof. Dr. ikfe GmbH, Institut for Klinische Forschung und Entwicklung, Parcusstr. 8, 55116 Mainz, Germany
Grünenthal GmbH
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP