Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310583
Status:
UNKNOWN
Last Update Posted:
2007-04-05
First Post:
2006-04-03
Brief Title:
Effects of Pregabalin on Mechanical Hyperalgesia
Sponsor:
Professional Associations Clinic Bergmannsheil
Organization:
Professional Associations Clinic Bergmannsheil
Study Overview
Official Title:
Effects of Pregabalin on Mechanical Hyperalgesia - EPOM
Status:
UNKNOWN
Status Verified Date:
2006-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this randomized placebo-controlled study is to evaluate the effects of analgetics for neuropathic pain on mechanical hyperalgesia as a kind of evoked pain Therefore the number of responders and non-responders on pregabalin will be evaluated in respect of mechanical hyperalgesia stimulus-response-function SRF on static punctual stimuli evoking pain determined via pinprick The hypothesis is that in the placebo group the amount of non-responders is increased
Detailed Description:
This randomized controlled trial is intended to be the first in a series of trials that will assess the efficacy of drugs which relieve neuropathic pain on stimulus-evoked pain here mechanical hyperalgesia to static punctate stimuli Most drugs in this class eg Gabapentin or NMDA receptor inhibitors have NNT beyond 3 in patients with chronic pain due to a response rate of 30 to 50 One potential reason for this low overall efficacy might be the presence of different pathophysiological mechanisms in subgroups of patients who suffer from the same disease eg postherpetic neuralgia diabetic neuropathy These mechanisms may include central sensitization on one hand and peripheral degeneration of afferent fibers on the other hand
In this trial we will use a battery of mechanical and thermal Quantitative Sensory Tests QST using non-nociceptive and low-intensity painful stimuli to identify a subgroup of patients with mechanical hyperalgesia To overcome the well-known low response rate in trials with neuropathic pain patients an enriched design comparing active drugs with placebo will be performed including only patients with high intensity of on-going pain in combination with mechanical hyperalgesia as sequelae of different but well defined neurological disorders The blinded phase of the trial will be restricted to so-called responders ie patients with a clinically meaningful pain reduction of at least 30 in the primary end point mechanical hyperalgesia The second objective of this trial is to evaluate whether the anti-hyperalgesic effect of the active drug is dependent on the QST profile
In this trial we will use a battery of mechanical and thermal Quantitative Sensory Tests QST using non-nociceptive and low-intensity painful stimuli to identify a subgroup of patients with mechanical hyperalgesia To overcome the well-known low response rate in trials with neuropathic pain patients an enriched design comparing active drugs with placebo will be performed including only patients with high intensity of on-going pain in combination with mechanical hyperalgesia as sequelae of different but well defined neurological disorders The blinded phase of the trial will be restricted to so-called responders ie patients with a clinically meaningful pain reduction of at least 30 in the primary end point mechanical hyperalgesia The second objective of this trial is to evaluate whether the anti-hyperalgesic effect of the active drug is dependent on the QST profile
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EV2005-2509 | None | None | None |
| BfArM61-3910-4030984 | None | None | None |
| 4478944789 | None | None | None |