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Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic

This study has been completed.
Sponsor:
Information provided by:
Grünenthal GmbH
ClinicalTrials.gov Identifier:
NCT00878293
First received: April 3, 2009
Last updated: August 19, 2010
Last verified: August 2010
History of Changes

April 3, 2009
August 19, 2010
April 2009
May 2010   (final data collection date for primary outcome measure)
Average daily pain intensity [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00878293 on ClinicalTrials.gov Archive Site
Quality of life Neuropathic pain scale Amount and first time of Rescue medication Adverse events, ECG, Laboratory values [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
Same as current
 
 
 
Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic
A Randomized Phase IIa Trial Evaluating the Safety and Efficacy of a New Centrally Acting Analgesic in Subjects With Pain Due to Diabetic Polyneuropathy

The purpose of this trial is to determine whether the new centrally active analgesic and MS Continus® are effective in the treatment of painful diabetic polyneuropathy.
 
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Diabetic Polyneuropathy
  • Drug: GRT6005
    liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
  • Drug: MS Continus®
    60 mg, capsule, once daily
  • Drug: Placebo
    liquid formulation and capsule, once daily
  • Experimental: A
    Dose 1, 40 µg
    Intervention: Drug: GRT6005
  • Experimental: B
    Dose 2, 120 µg
    Intervention: Drug: GRT6005
  • Experimental: C
    Dose 3
    Intervention: Drug: GRT6005
  • Experimental: D
    Dose 4
    Intervention: Drug: GRT6005
  • Experimental: E
    Dose 5
    Intervention: Drug: GRT6005
  • Experimental: F
    Dose 6
    Intervention: Drug: GRT6005
  • Experimental: G
    Dose 7
    Intervention: Drug: GRT6005
  • Active Comparator: H
    Morphin
    Intervention: Drug: MS Continus®
  • Placebo Comparator: I
    Placebo
    Intervention: Drug: Placebo
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with pain at least NRS >4 due to painful diabetic polyneuropaty.

Exclusion Criteria:

  • Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients.
  • non Caucasian or Hispanic.
  • Concomitant painful disease.
  • Life-long history of seizure disorder or epilepsy.
  • Subjects with clinical relevant cardiac and vascular diseases.
  • Subjects with impaired renal function
  • Subjects with impaired hepatic function
  • Female subjects who are pregnant or breastfeeding.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United Kingdom
 
NCT00878293
449723
No
Grünenthal GmbH
Grünenthal GmbH
 
Principal Investigator: Thomas Forst, Prof. Dr. med IKFE, Parcusstr. 8, 55116 Mainz
Grünenthal GmbH
August 2010

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