Back to resultsPainful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic
Primary Purpose
Diabetic Polyneuropathy
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GRT6005
MS Continus®
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Polyneuropathy focused on measuring analgesic, diabetes mellitus, chronic neuropathic pain, painful polyneuropathy caused by diabetes mellitus type I or II
Eligibility Criteria
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.
Sites / Locations
- Investigator 3
- Investigator 1
- Investigator 2
- Investigator 4
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
A
B
C
D
E
F
G
H
I
Arm Description
Dose 1, 40 µg
Dose 2, 120 µg
Dose 3
Dose 4
Dose 5
Dose 6
Dose 7
Morphin
Placebo
Outcomes
Primary Outcome Measures
Average daily pain intensity
Secondary Outcome Measures
Quality of life Neuropathic pain scale Amount and first time of Rescue medication Adverse events, ECG, Laboratory values
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00878293
Brief Title
Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic
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 Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tris Pharma, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Polyneuropathy
Keywords
analgesic, diabetes mellitus, chronic neuropathic pain, painful polyneuropathy caused by diabetes mellitus type I or II
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Dose 1, 40 µg
Arm Title
B
Arm Type
Experimental
Arm Description
Dose 2, 120 µg
Arm Title
C
Arm Type
Experimental
Arm Description
Dose 3
Arm Title
D
Arm Type
Experimental
Arm Description
Dose 4
Arm Title
E
Arm Type
Experimental
Arm Description
Dose 5
Arm Title
F
Arm Type
Experimental
Arm Description
Dose 6
Arm Title
G
Arm Type
Experimental
Arm Description
Dose 7
Arm Title
H
Arm Type
Active Comparator
Arm Description
Morphin
Arm Title
I
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
GRT6005
Intervention Description
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Intervention Type
Drug
Intervention Name(s)
MS Continus®
Intervention Description
60 mg, capsule, once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
liquid formulation and capsule, once daily
Primary Outcome Measure Information:
Title
Average daily pain intensity
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Quality of life Neuropathic pain scale Amount and first time of Rescue medication Adverse events, ECG, Laboratory values
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Forst, Prof. Dr. med
Organizational Affiliation
IKFE, Parcusstr. 8, 55116 Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigator 3
City
Bad Oeynhausen
Country
Germany
Facility Name
Investigator 1
City
Mainz
Country
Germany
Facility Name
Investigator 2
City
Münster
Country
Germany
Facility Name
Investigator 4
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
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Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic
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