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Completed

NCT Number: NCT00878293

Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic

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.

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Key information

Conditions

Diabetic Polyneuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigator 3, Bad Oeynhausen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GRT6005

Drug

liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days

MS Continus®

Drug

60 mg, capsule, once daily

Placebo

Drug

liquid formulation and capsule, once daily

Primary outcomes

  1. Average daily pain intensity

    Time frame: 5 days

Secondary outcomes

  1. Quality of life Neuropathic pain scale Amount and first time of Rescue medication Adverse events, ECG, Laboratory values

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Tris Pharma, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 8, 2009
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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