Status:
TERMINATED
The Effects of Topical Treatment With Clonidine + Pentoxifylline in Patients With Neuropathic Pain
Lead Sponsor:
Terence J. Coderre
Collaborating Sponsors:
The Louise And Alan Edwards Foundation
Conditions:
Neuralgia Peripheral
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Microvascular dysfunction underlies pain in different animal models of neuropathic pain. Pentoxifylline is a phosphodiesterase inhibitor that reduces cyclic adenosine monophosphate (cAMP) hydrolysis, ...
Eligibility Criteria
Inclusion
- Female or male patients, aged 18-70;
- An average spontaneous pain level of at least 4 on an 11-point numerical rating pain score (0= no pain, 10= worst pain possible) on at least 3 days during the week prior to the study;
- The existence of tactile allodynia, as a sign of chronic pain, following a traumatic peripheral nerve injury;
- Ability to communicate in English or in French;
- Willing and able to sign an informed consent;
- Stable pain disease with no anticipated change in treatment in the next 5 weeks.
- Female subjects of childbearing potential must agree to use effective method of contraception during the study period. Female subjects who utilize a hormonal contraceptive as one of their birth control methods must have consistently used the same method for at least three months prior to study drug dosing.
Exclusion
- Diabetes mellitus necessitating antihyperglycemic treatment or any other endocrine disease;
- Any liver disease, resulting in aspartate aminotransferase (AST) levels greater than 3 times the normal values, or kidney disease, resulting in creatinine levels greater than 133 µmol/L;
- Hypertension or taking of anti-hypertensive medication;
- Malignant disease or taking of chemotherapeutic agents;
- Known diagnosis of angina pectoris, arrhythmias, congestive heart failure or peripheral arterial disease;
- Pregnancy or breast feeding. Female patients of child-bearing age must have a negative urine pregnancy test;
- Known allergic reaction to clonidine or pentoxifylline;
- Presence of major depression, bipolar affective disorder or schizophrenia;
- Presence of a severe medical condition, or condition known to affect peripheral circulation (intermittent claudication, peripheral arterial disease, Raynaud's syndrome);
- any medication that interacts with clonidine or pentoxifylline \[e.g. cardiovascular drugs such as angiotensin converting enzyme (ACE) inhibitors, alpha blockers (prazosin, terazosin or doxazosin), beta blockers (atenolol, metoprolol, propranolol), neuroleptics (butyrophenones, phenothiazines, thioxanthenes), calcium channel blockers (verapamil, diltiazem) and non-cardiovascular drugs such as diuretics, thyroxine, monoamine oxidase inhibitors and selective serotonin reuptake inhibitors (SSRIs), as well as vitamin K antagonists/blood thinners, such as warfarin\];
- any medical condition that might be impacted by clonidine or pentoxifylline, such as cardiovascular disease, cardiac rhythm disorders (atrial-ventricular blockade or conduction abnormalities), orthostatic regulation disturbances, disorders of cerebral perfusion, chronic renal failure; sinus node dysfunction, or a recent cerebral and/or retinal haemorrhage.
Key Trial Info
Start Date :
February 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03342950
Start Date
February 19 2019
End Date
October 12 2021
Last Update
October 21 2021
Active Locations (1)
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1
McGill University
Montreal, Quebec, Canada, H3G 1Y6