Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy
A Randomized 4-week Phase IIa Trial Evaluating the Efficacy, Safety, and Tolerability of GRT6005, a New Centrally Acting Analgesic, in Subjects With Pain Due to Diabetic Polyneuropathy.
2 other identifiers
interventional
189
3 countries
22
Brief Summary
The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pain
Started May 2011
Shorter than P25 for phase_2 pain
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 2, 2011
CompletedFirst Posted
Study publicly available on registry
May 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJuly 15, 2021
July 1, 2021
8 months
May 2, 2011
July 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in mean daily pain intensity score
Participants will be selected based on their medical history and clinical examination. Efficacy of the treatment (i.e., reduction of pain) will be evaluated with the 11-point numeric rating scale (NRS), where 0 represents no pain and 10 represents "pain as bad as you can imagine".
Baseline to Week 4
Secondary Outcomes (11)
Response measured in percentage change of pain intensity from baseline
End of 4 Weeks
Changes in Quantitative Sensory Testing from baseline
Baseline, week 1 and week 4
Neuropathic Pain Scale, changes from baseline
End of 4 weeks
Short Form of the Brief Pain Inventory, changes from baseline
End of 4 weeks
Leeds Sleep Evaluation Questionnaire
End of treatment
- +6 more secondary outcomes
Study Arms (4)
25 µg GRT6005
ACTIVE COMPARATORParticipants allocated to this treatment arm will receive a daily dose of 25 µg GRT6005 per day
75 µg GRT6005
ACTIVE COMPARATORParticipants allocated to this treatment arm will receive a daily dose of 75 µg GRT6005 per day
200 µg GRT6005
ACTIVE COMPARATORParticipants allocated to this treatment arm will receive a daily dose of 200 µg GRT6005 per day
Matching Placebo
PLACEBO COMPARATORParticipants allocated to this treatment arm will receive a dose of matched placebo once a day.
Interventions
Eligibility Criteria
You may qualify if:
- Men and women, 18 to 75 years old.
- 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.
You may not qualify if:
- Impaired liver, cardiac or renal function.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tris Pharma, Inc.lead
- Forest Laboratoriescollaborator
Study Sites (22)
Site 4502
Sofia, 1431, Bulgaria
Site 4112
Aschaffenburg, 63739, Germany
Site 4109
Bad Oeynhausen, 32545, Germany
Site 4101
Berlin, 10117, Germany
Site 4110
Berlin, 13125, Germany
Site 4111
Dresden, 01307, Germany
Site 4107
Hamburg, 20253, Germany
Site 4117
Hamburg, 22587, Germany
Site 4108
Hanover, 30159, Germany
Site 4104
Hanover, 30167, Germany
Site 4115
Heidelberg, 69120, Germany
Site 4106
Kiel, 24119, Germany
Site 4102
Lübeck, 23562, Germany
Site 4103
Mainz, 55116, Germany
Site 4105
Münster, 48145, Germany
Site 4113
Schwerin, 19055, Germany
Site 4116
Wangen, 88239, Germany
Site 4405
Bucharest, 010496, Romania
Site 4402
Bucharest, 011025, Romania
Site 4407
Sibiu, 550166, Romania
Site 4401
Târgu Mureş, 540139, Romania
Site 4406
Timișoara, 300594, Romania
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Forst, Prof. Dr.
ikfe GmbH, Institut for Klinische Forschung und Entwicklung, Parcusstr. 8, 55116 Mainz, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2011
First Posted
May 4, 2011
Study Start
May 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
July 15, 2021
Record last verified: 2021-07