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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
  Purpose

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.


Condition Intervention Phase
Diabetic Polyneuropathy
 Drug: GRT6005
Drug: MS Continus®
Drug: Placebo
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Grünenthal GmbH:

Primary Outcome Measures:
  • Average daily pain intensity [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 90
Study Start Date: April 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Dose 1, 40 µg
 Drug: GRT6005
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: B
Dose 2, 120 µg
 Drug: GRT6005
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: C
Dose 3
 Drug: GRT6005
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: D
Dose 4
 Drug: GRT6005
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: E
Dose 5
 Drug: GRT6005
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: F
Dose 6
 Drug: GRT6005
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: G
Dose 7
 Drug: GRT6005
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Active Comparator: H
Morphin
 Drug: MS Continus®
60 mg, capsule, once daily
Placebo Comparator: I
Placebo
 Drug: Placebo
liquid formulation and capsule, once daily

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00878293

Locations
Germany
Investigator 3
Bad Oeynhausen, Germany
Investigator 1
Mainz, Germany
Investigator 2
Münster, Germany
United Kingdom
Investigator 4
Manchester, United Kingdom
Sponsors and Collaborators
Grünenthal GmbH
Investigators
Principal Investigator: Thomas Forst, Prof. Dr. med IKFE, Parcusstr. 8, 55116 Mainz
  More Information

No publications provided

Responsible Party: Grünenthal GmbH
ClinicalTrials.gov Identifier: NCT00878293     History of Changes
Other Study ID Numbers: 449723
Study First Received: April 3, 2009
Last Updated: August 19, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Grünenthal GmbH:
analgesic
diabetes mellitus
chronic neuropathic pain
painful polyneuropathy caused by diabetes mellitus type I or II

Additional relevant MeSH terms:
Polyneuropathies
Diabetic Neuropathies
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 May 21, 2013