Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic

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Tris Pharma

Status and phase

Completed
Phase 2

Conditions

Diabetic Polyneuropathy

Treatments

Drug: MS Continus®
Drug: GRT6005
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00878293
449723

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

90 participants in 9 patient groups, including a placebo group

A
Experimental group
Description:
Dose 1, 40 µg
Treatment:
Drug: GRT6005
B
Experimental group
Description:
Dose 2, 120 µg
Treatment:
Drug: GRT6005
C
Experimental group
Description:
Dose 3
Treatment:
Drug: GRT6005
D
Experimental group
Description:
Dose 4
Treatment:
Drug: GRT6005
E
Experimental group
Description:
Dose 5
Treatment:
Drug: GRT6005
F
Experimental group
Description:
Dose 6
Treatment:
Drug: GRT6005
G
Experimental group
Description:
Dose 7
Treatment:
Drug: GRT6005
H
Active Comparator group
Description:
Morphin
Treatment:
Drug: MS Continus®
I
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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