Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy

Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347671
• Other study ID #: 430409
• Secondary ID: 2010-022557-42
• Status: Completed
• Phase: Phase 2
• Start date: May 2011
• Est. completion date: January 2012

Study information

• Verified date: July 2021
• Source: Tris Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Pain
• Polyneuropathies

Intervention

Drug:
• GRT6005
25µg/day once daily
• GRT6005
75 µg/day once daily
• GRT6005
200 µg/day once daily
• Matching Placebo
Once daily

Locations

Country	Name	City	State
Bulgaria	Site 4502	Sofia
Germany	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 4104	Hannover
Germany	Site 4108	Hannover
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
Romania	Site 4402	Bucuresti
Romania	Site 4405	Bucuresti
Romania	Site 4407	Sibiu
Romania	Site 4401	Târgu-Mures
Romania	Site 4406	Timisoara

Sponsors (2)

Lead Sponsor	Collaborator
Tris Pharma, Inc.	Forest Laboratories

Countries where clinical trial is conducted

Bulgaria,  Germany,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Response measured in percentage change of pain intensity from baseline		End of 4 Weeks
Secondary	Changes in Quantitative Sensory Testing from baseline		Baseline, week 1 and week 4
Secondary	Neuropathic Pain Scale, changes from baseline		End of 4 weeks
Secondary	Short Form of the Brief Pain Inventory, changes from baseline		End of 4 weeks
Secondary	Leeds Sleep Evaluation Questionnaire		End of treatment
Secondary	Quality of Life Index -Short-Form-12®, from baseline		End of treatment
Secondary	Patient's Global Impression of Change		End of treatment
Secondary	Quality of Life EuroQoL-5 Dimension score, change from baseline		End of 4 weeks
Secondary	Rescue medication use		End of 4 weeks
Secondary	Clinical Opioid Withdrawal Scale		End of 4 weeks
Secondary	Plasma concentration		End of 4 weeks