Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00377598
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2006-09-14
Brief Title:
Efficacy Safety and Tolerability Study of TAK-583 in Subjects With Postherpetic Neuralgia
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 2 Double Blind Placebo Controlled Dose-Ranging Study in Subjects With Postherpetic Neuralgia PHN to Evaluate the Efficacy Safety Tolerability and Pharmacokinetics of Four Doses of TAK-583 Compared With Placebo
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
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 purpose of this study is to evaluate the efficacy of TAK-583 once daily QD in relieving pain in subjects with postherpetic neuralgia
Detailed Description:
Postherpetic neuralgia is defined as neuropathic pain still present 3 months following healing of the herpes zoster rash Symptoms of postherpetic neuralgia may include a complex combination of symptoms including a deep aching shooting or burning pain sensory deficits hyperalgesia allodynia paresthesia and dysesthesia Postherpetic neuralgia is more common in the elderly and it can have a debilitating effect on a patient The most commonly prescribed treatments are tricyclic antidepressants and anticonvulsants however these treatments are effective in approximately half of subjects and may also have undesirable side effects eg dizziness and somnolence
TAK-583 is a synthetic compound under development by Takeda Global Research Development Center Inc as a treatment for neuropathic pain and for delaying the progression of diabetic neuropathy
Individuals who want to participate in this study will be required to provide written informed consent Study participation is anticipated to be about 11 Weeks Multiple procedures will occur at each visit which may include fasting blood collection urine collection vital signs body height and weight physical examinations and electrocardiograms
TAK-583 is a synthetic compound under development by Takeda Global Research Development Center Inc as a treatment for neuropathic pain and for delaying the progression of diabetic neuropathy
Individuals who want to participate in this study will be required to provide written informed consent Study participation is anticipated to be about 11 Weeks Multiple procedures will occur at each visit which may include fasting blood collection urine collection vital signs body height and weight physical examinations and electrocardiograms
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 |
|---|---|---|---|
| U1111-1127-6187 | REGISTRY | WHO | None |
| 2005-005863-26 | EUDRACT_NUMBER | None | None |