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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01347671

Enrollment

189

Registered

2011-05-04

Start date

2011-05-31

Completion date

2012-01-31

Last updated

2021-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathies, Pain

Keywords

analgesia, analgesics, pain, chronic pain, neuropathic pain

Brief summary

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

Interventions

DRUGGRT6005

25µg/day once daily

DRUGMatching Placebo

Once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in mean daily pain intensity score	Baseline to Week 4	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.

Secondary

Measure	Time frame
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
Quality of Life Index -Short-Form-12®, from baseline	End of treatment
Response measured in percentage change of pain intensity from baseline	End of 4 Weeks
Quality of Life EuroQoL-5 Dimension score, change from baseline	End of 4 weeks
Rescue medication use	End of 4 weeks
Clinical Opioid Withdrawal Scale	End of 4 weeks
Plasma concentration	End of 4 weeks
Patient's Global Impression of Change	End of treatment

Countries

Bulgaria, Germany, Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026