Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Diabetic Polyneuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Dose 1, 40 µg

Group Type EXPERIMENTAL

GRT6005

Intervention Type DRUG

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

B

Dose 2, 120 µg

Group Type EXPERIMENTAL

GRT6005

Intervention Type DRUG

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

C

Dose 3

Group Type EXPERIMENTAL

GRT6005

Intervention Type DRUG

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

D

Dose 4

Group Type EXPERIMENTAL

GRT6005

Intervention Type DRUG

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

E

Dose 5

Group Type EXPERIMENTAL

GRT6005

Intervention Type DRUG

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

F

Dose 6

Group Type EXPERIMENTAL

GRT6005

Intervention Type DRUG

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

G

Dose 7

Group Type EXPERIMENTAL

GRT6005

Intervention Type DRUG

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

H

Morphin

Group Type ACTIVE_COMPARATOR

MS Continus®

Intervention Type DRUG

60 mg, capsule, once daily

I

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

liquid formulation and capsule, once daily

Interventions

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GRT6005

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

Intervention Type DRUG

MS Continus®

60 mg, capsule, once daily

Intervention Type DRUG

Placebo

liquid formulation and capsule, once daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No