Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic

Phase 2

Completed

• Conditions: Diabetic Polyneuropathy
• Interventions: Drug: Placebo; Drug: MS Continus®; Drug: GRT6005

• Registration Number: NCT00878293
• Lead Sponsor: Tris Pharma, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-07
• Study First Posted: 2009-04-08
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
I	Placebo	Placebo
H	MS Continus®	Morphin
D	GRT6005	Dose 4
F	GRT6005	Dose 6
G	GRT6005	Dose 7
A	GRT6005	Dose 1, 40 µg
B	GRT6005	Dose 2, 120 µg
C	GRT6005	Dose 3
E	GRT6005	Dose 5

Primary Outcome Measures

Name	Time	Method
Average daily pain intensity	5 days

Secondary Outcome Measures

Name	Time	Method
Quality of life Neuropathic pain scale Amount and first time of Rescue medication Adverse events, ECG, Laboratory values	5 days

Trial Locations

Locations (4)

Investigator 3; 🇩🇪 Bad Oeynhausen, Germany

Investigator 1; 🇩🇪 Mainz, Germany

Investigator 2; 🇩🇪 Münster, Germany

Investigator 4; 🇬🇧 Manchester, United Kingdom