Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves



Status:Completed
Conditions:Chronic Pain, Chronic Pain, Diabetic Neuropathy, Neurology, Diabetes
Therapuetic Areas:Endocrinology, Musculoskeletal, Neurology
Healthy:No
Age Range:18 - 80
Updated:2/7/2015
Start Date:September 2013
End Date:February 2015
Contact:Grünenthal Clinical Trial Help Desk
Email:Clinical-Trials@grunenthal.com
Phone:+49 241 569 3223

Use our guide to learn which trials are right for you!

Efficacy, Safety and Tolerability of Multiple Doses of Oral Cebranopadol in Subjects With Moderate to Severe Chronic Pain Due to Diabetic Peripheral Neuropathy.

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.


Inclusion Criteria:

- written signed informed consent

- type 1 or type 2 diabetes mellitus

- clinical diagnosis of painful Diabetic Polyneuropathic Neuropathy (DPN) with symptoms
and signs for at least 3 months

- must require medication (e.g., non-opioids or opioids up to an equivalent dose of 160
mg oral morphine/day) for the treatment of pain due to DPN for at least 1 month prior
to Visit 1 and must be dissatisfied with the current treatment (in terms of efficacy
and/or tolerability). Medication for the treatment of pain due to DPN should be
required on at least 4 of 7 consecutive days.

- blood glucose to be controlled by a diet, oral anti-hyperglycemic medication, and/or
insulin for at least 3 months prior. Glycosylated hemoglobin (HbA1C) should not be
greater than 11%

- baseline pain intensity score greater or equal to 5 on the 11-point Numerical Rating
Scale (NRS) without intake of any analgesic at allocation. For each of the last 3
days prior to allocation of treatment, a 24 hour NRS score greater or equal to 4 is
required

- women of childbearing potential must have a negative urine pregnancy test at
enrollment

- using medically acceptable and highly effective methods of birth control (and willing
to use them during the trial).

Exclusion Criteria:

- presence of other pain that could confound the painful Diabetic Polyneuropathy (DPN)
assessments, e.g. pain due to nerve entrapment (tarsal tunnel syndrome,
osteoarthritis of the knee etc), peripheral vascular disease, radiculopathy, plantar
fasciitis, tendonitis, mononeuritis multiplex, postherpetic neuralgia, complex
regional pain syndrome, or fibromyalgia.

- neuropathy due to etiologies other than diabetes, e.g. autoimmune disorders,
inflammatory neuropathies (e.g. chronic inflammatory demyelinating polyneuropathy),
thyroid disease or endocrine disorders (other than diabetes), heavy metal or toxic
neuropathy, nutritional deficiency, metabolic disorders, vasculitis, infections,
injury, or paraneoplastic syndromes.

- severe or extensive diabetic ulcers or amputations due to diabetes

- Charcot's

- any clinically significant disease or laboratory findings, e.g., significant unstable
cardiac, vascular, pulmonary, gastrointestinal, endocrine, metabolic, neurological,
or psychiatric disorders.

- inability to comply with the protocol and with the intake of trial medication that,
in the investigator's opinion, might indicate that the participant is unsuitable for
the trial.

- conditions that require treatment with medication that is not allowed to be taken
during the trial

- previous or current alcohol or drug abuse or opioid dependency.

- severe functional hepatic impairment corresponding to Child-Pugh classification C.

- history of acute hepatitis

- impaired renal function, a creatinine clearance less than 60 mL/min at the enrollment
(Cockcroft-Gault calculated).

- history of any major gastrointestinal procedures (e.g., gastric bypass) or
gastrointestinal conditions (e.g. acute diarrhea, blind loop syndrome, gastric
dumping syndrome, Whipple's disease) that might affect the absorption or metabolism
of cebranopadol or pregabalin.

- risk factors for or history of torsade de pointes and/or marked prolongation of the
QT interval (e.g. heart failure, hypokalemia, or bradycardia).

- history of seizure disorder and/or epilepsy or any condition associated with a
significant risk for seizure disorder or epilepsy at the discretion of the
investigator.
We found this trial at
15
sites
Miami, Florida 33135
?
mi
from
Miami, FL
Click here to add this to my saved trials
Blackfoot, Idaho 83221
?
mi
from
Blackfoot, ID
Click here to add this to my saved trials
Brooklyn, New York 11235
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Brooklyn, New York 11229
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Elgin, Illinois 60123
?
mi
from
Elgin, IL
Click here to add this to my saved trials
Garden Grove, California 92843
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
Hialeah, Florida 33012
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Laguna Hills, California 92653
?
mi
from
Laguna Hills, CA
Click here to add this to my saved trials
Mesa, Arizona 85215
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
National City, California 91950
?
mi
from
National City, CA
Click here to add this to my saved trials
New York, New York 10128
?
mi
from
New York, NY
Click here to add this to my saved trials
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
West Jordan, Utah 84088
?
mi
from
West Jordan, UT
Click here to add this to my saved trials
West Long Branch, New Jersey 07764
?
mi
from
West Long Branch, NJ
Click here to add this to my saved trials