Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy

Sponsor

Tris Pharma, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01347671

Collaborator

Forest Laboratories (Industry)

189

Enrollment

Locations

Arms

Duration (Months)

8.6

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain Diabetic Neuropathies	Drug: GRT6005 Drug: GRT6005 Drug: GRT6005 Drug: Matching Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

189 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2011

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 25 µg GRT6005 Participants allocated to this treatment arm will receive a daily dose of 25 µg GRT6005 per day	Drug: GRT6005 25µg/day once daily
Active Comparator: 75 µg GRT6005 Participants allocated to this treatment arm will receive a daily dose of 75 µg GRT6005 per day	Drug: GRT6005 75 µg/day once daily
Active Comparator: 200 µg GRT6005 Participants allocated to this treatment arm will receive a daily dose of 200 µg GRT6005 per day	Drug: GRT6005 200 µg/day once daily
Placebo Comparator: Matching Placebo Participants allocated to this treatment arm will receive a dose of matched placebo once a day.	Drug: Matching Placebo Once daily

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
Quality of Life Index -Short-Form-12®, from baseline [End of treatment]
Patient's Global Impression of Change [End of treatment]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Site 4502	Sofia	Bulgaria	1431
2	Site 4112	Aschaffenburg	Germany	63739
3	Site 4109	Bad Oeynhausen	Germany	32545
4	Site 4101	Berlin	Germany	10117
5	Site 4110	Berlin	Germany	13125
6	Site 4111	Dresden	Germany	01307
7	Site 4107	Hamburg	Germany	20253
8	Site 4117	Hamburg	Germany	22587
9	Site 4108	Hannover	Germany	30159
10	Site 4104	Hannover	Germany	30167
11	Site 4115	Heidelberg	Germany	69120
12	Site 4106	Kiel	Germany	24119
13	Site 4102	Lübeck	Germany	23562
14	Site 4103	Mainz	Germany	55116
15	Site 4105	Münster	Germany	48145
16	Site 4113	Schwerin	Germany	19055
17	Site 4116	Wangen	Germany	88239
18	Site 4405	Bucuresti	Romania	010496
19	Site 4402	Bucuresti	Romania	011025
20	Site 4407	Sibiu	Romania	550166
21	Site 4406	Timisoara	Romania	300594
22	Site 4401	Târgu-Mureş	Romania	540139