Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic

Sponsor

Tris Pharma, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00878293

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

22.5

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Polyneuropathy	Drug: GRT6005 Drug: MS Continus® Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official 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

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Dose 1, 40 µg	Drug: GRT6005 liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: B Dose 2, 120 µg	Drug: GRT6005 liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: C Dose 3	Drug: GRT6005 liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: D Dose 4	Drug: GRT6005 liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: E Dose 5	Drug: GRT6005 liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: F Dose 6	Drug: GRT6005 liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: G Dose 7	Drug: GRT6005 liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Active Comparator: H Morphin	Drug: MS Continus® 60 mg, capsule, once daily
Placebo Comparator: I Placebo	Drug: Placebo liquid formulation and capsule, once daily

Outcome Measures

Primary Outcome Measures

Average daily pain intensity [5 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.