Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic

NCT00878293 | Completed Phase 2

• 1 other identifier: 449723
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Diabetic Polyneuropathy

Keywords

analgesic; diabetes mellitus; chronic neuropathic pain; painful polyneuropathy caused by diabetes mellitus type I or II

Outcome Measures

Primary Outcomes (1)

• Average daily pain intensity

  5 days

Secondary Outcomes (1)

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

  5 days

Study Arms (9)

A

EXPERIMENTAL

Dose 1, 40 µg

Drug: GRT6005

B

EXPERIMENTAL

Dose 2, 120 µg

Drug: GRT6005

C

EXPERIMENTAL

Dose 3

Drug: GRT6005

D

EXPERIMENTAL

Dose 4

Drug: GRT6005

E

EXPERIMENTAL

Dose 5

Drug: GRT6005

F

EXPERIMENTAL

Dose 6

Drug: GRT6005

G

EXPERIMENTAL

Dose 7

Drug: GRT6005

H

ACTIVE COMPARATOR

Morphin

Drug: MS Continus®

I

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

GRT6005 DRUG

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

A; B; C; D; E; F; G

MS Continus® DRUG

60 mg, capsule, once daily

H

Placebo DRUG

liquid formulation and capsule, once daily

I

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tris Pharma, Inc.: lead

Study Sites (4)

Investigator 3

Bad Oeynhausen, Germany

Location

Investigator 1

Mainz, Germany

Location

Investigator 2

Münster, Germany

Location

Investigator 4

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Thomas Forst, Prof. Dr. med

  IKFE, Parcusstr. 8, 55116 Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: April 8, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 15, 2021

Record last verified: 2021-07

Locations

DE (3); GB (1)