Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves
The purpose of this trial is to evaluate if cebranopadol is safe and can decrease pain in patients when compared to placebo (a tablet that does not contain active product) and when compared to a marketed product containing pregabalin (Lyrica®, indicated for your pain condition). Furthermore, this trial will be undertaken to find out if the patient's general health and well-being improves under trial treatment.
The concentrations of cebranopadol in the blood will be investigated to get a better understanding of how it is absorbed from the gut, distributed and broken down in the body, and eliminated from the body.
|Chronic Pain Diabetic Neuropathies Diabetes Mellitus||Drug: Cebranopadol 100 µg Drug: Cebranopadol 300 µg Drug: Cebranopadol 600 µg Drug: Pregabalin Drug: Matching Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy, Safety and Tolerability of Multiple Doses of Oral Cebranopadol in Subjects With Moderate to Severe Chronic Pain Due to Diabetic Peripheral Neuropathy.|
- Change in average pain intensity. [ Time Frame: Baseline; to end of Week 6 of the Maintenance Phase ]Participants will be asked to record their pain intensity in the evening. Participants are asked to rate how much pain they had on average in the past 24 hours. The participant scores their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Baseline average pain scores are calculated from the averages of all scores recorded during the 3 days prior to randomization. The average pain at week 6 will be the average pain scores calculated from all pain scores measured during week 6.
|Study Start Date:||September 2013|
|Study Completion Date:||January 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
|Experimental: Cebranopadol 300 µg||
Drug: Cebranopadol 300 µg
Participants randomized to 300 μg cebranopadol will start with 100 μg per day and increase to 300 µg per day on day 4 and will remain on 300 µg per day.
|Experimental: Cebranopadol 600 µg||
Drug: Cebranopadol 600 µg
Participants randomized to 600 μg cebranopadol will start with 200 μg per day and increase to 400 µg per day on day 4 and to 600 µg on day 7, thereafter they will remain on 600 µg per day.
|Active Comparator: Pregabalin||
Stepwise titration from 75 mg twice a day to 300 mg twice a day over 2 weeks.
Other Name: Lyrica®
|Placebo Comparator: Matching Placebo||
Drug: Matching Placebo
Placebo will be matched to pregabalin and cebranopadol.
|Experimental: Cebranopadol 100 µg||
Drug: Cebranopadol 100 µg
Participants randomized to 100 μg cebranopadol will start with 100 μg per day and will remain on 100 µg per day.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01939366
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|Study Director:||Director Clinical Trials||Grünenthal GmbH|