Clinical trial NCT01347671: Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Diabetic Neuropathies
Keywords: analgesia
analgesics
pain
chronic pain
neuropathic pain
Lead sponsor: Tris Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Forest Laboratories
First posted: 2011-05-04
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in mean daily pain intensity score
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Response measured in percentage change of pain intensity from baseline
timeFrame: End of 4 Weeks
measure: Changes in Quantitative Sensory Testing from baseline
timeFrame: Baseline, week 1 and week 4
measure: Neuropathic Pain Scale, changes from baseline
timeFrame: End of 4 weeks
measure: Short Form of the Brief Pain Inventory, changes from baseline
timeFrame: End of 4 weeks
measure: Leeds Sleep Evaluation Questionnaire
timeFrame: End of treatment
measure: Quality of Life Index -Short-Form-12®, from baseline
timeFrame: End of treatment
measure: Patient's Global Impression of Change
timeFrame: End of treatment
measure: Quality of Life EuroQoL-5 Dimension score, change from baseline
timeFrame: End of 4 weeks
measure: Rescue medication use
timeFrame: End of 4 weeks
measure: Clinical Opioid Withdrawal Scale
timeFrame: End of 4 weeks
measure: Plasma concentration
timeFrame: End of 4 weeks
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Site 4502
city: Aschaffenburg
country: Germany
facility: Site 4112
city: Bad Oeynhausen
country: Germany
facility: Site 4109
city: Berlin
country: Germany
facility: Site 4101
city: Berlin
country: Germany
facility: Site 4110
city: Dresden
country: Germany
facility: Site 4111
city: Hamburg
country: Germany
facility: Site 4107
city: Hamburg
country: Germany
facility: Site 4117
city: Hannover
country: Germany
facility: Site 4108
city: Hannover
country: Germany
facility: Site 4104
city: Heidelberg
country: Germany
facility: Site 4115
city: Kiel
country: Germany
facility: Site 4106
city: Lübeck
country: Germany
facility: Site 4102
city: Mainz
country: Germany
facility: Site 4103
city: Münster
country: Germany
facility: Site 4105
city: Schwerin
country: Germany
facility: Site 4113
city: Wangen
country: Germany
facility: Site 4116
city: Bucuresti
country: Romania
facility: Site 4405
city: Bucuresti
country: Romania
facility: Site 4402
city: Sibiu
country: Romania
facility: Site 4407
city: Timisoara
country: Romania
facility: Site 4406
city: Târgu-Mureş
country: Romania
facility: Site 4401
Study officials:
affiliation: ikfe GmbH, Institut for Klinische Forschung und Entwicklung, Parcusstr. 8, 55116 Mainz, Germany
name: Thomas Forst, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: