Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy
NCT ID: NCT01347671
Last Updated: 2021-07-15
Study Results
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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COMPLETED
PHASE2
189 participants
INTERVENTIONAL
2011-05-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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25 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 25 µg GRT6005 per day
GRT6005
25µg/day once daily
75 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 75 µg GRT6005 per day
GRT6005
75 µg/day once daily
200 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 200 µg GRT6005 per day
GRT6005
200 µg/day once daily
Matching Placebo
Participants allocated to this treatment arm will receive a dose of matched placebo once a day.
Matching Placebo
Once daily
Interventions
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GRT6005
25µg/day once daily
GRT6005
75 µg/day once daily
GRT6005
200 µg/day once daily
Matching Placebo
Once daily
Eligibility Criteria
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Inclusion Criteria
* Type 1 or type 2 diabetes.
* Painful DPN symptoms and signs for at least 3 months.
* Blood glucose controlled with medication.
* Glycosylated hemoglobin not greater than 9.5 or 11%, country dependent.
* Prior analgesic medication.
* Average score of 4 or greater on the 11 point NRS during the last 3 days prior to randomization.
Exclusion Criteria
* Breastfeeding and pregnancy.
* History of substance abuse, alcohol or medication.
* Chronic gastrointestinal disease.
* History of seizures and or epilepsy.
* History or presence of malignancy.
* Presence of painful medical conditions that are not due to diabetic neuropathy, e.g. rheumatoid arthritis.
* Allergies to opioids, acetaminophen or excipients of the medications.
18 Years
75 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Tris Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Forst, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
ikfe GmbH, Institut for Klinische Forschung und Entwicklung, Parcusstr. 8, 55116 Mainz, Germany
Locations
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Site 4502
Sofia, , Bulgaria
Site 4112
Aschaffenburg, , Germany
Site 4109
Bad Oeynhausen, , Germany
Site 4101
Berlin, , Germany
Site 4110
Berlin, , Germany
Site 4111
Dresden, , Germany
Site 4107
Hamburg, , Germany
Site 4117
Hamburg, , Germany
Site 4108
Hanover, , Germany
Site 4104
Hanover, , Germany
Site 4115
Heidelberg, , Germany
Site 4106
Kiel, , Germany
Site 4102
Lübeck, , Germany
Site 4103
Mainz, , Germany
Site 4105
Münster, , Germany
Site 4113
Schwerin, , Germany
Site 4116
Wangen, , Germany
Site 4405
Bucharest, , Romania
Site 4402
Bucharest, , Romania
Site 4407
Sibiu, , Romania
Site 4401
Târgu Mureş, , Romania
Site 4406
Timișoara, , Romania
Countries
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Other Identifiers
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2010-022557-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
430409
Identifier Type: -
Identifier Source: org_study_id
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