Clinical trial NCT00414466: A Safety and Effectiveness Study of Intraspinal Gabapentin (MDT2004) for the Treatment of Chronic Pain
Official title: A Randomized Double Blind, Placebo-controlled, Dose Response Study of Intraspinal Gabapentin (MDT2004) in Subjects With Chronic, Intractable Pain.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Intractable Pain
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2006-12-21
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and minimum effective dose of intraspinal gabapentin when delivered through an implanted drug infusion system.


Eligibility criteria: Inclusion Criteria:

* Chronic pain below the neck present for a minimum of one year.
* Diagnosis of at least one of the following:

  * back pain with or without leg pain,
  * post-herpetic neuralgia,
  * complex regional pain syndrome (CRPS) 1 or 2,
  * diabetic neuropathy,
  * or a general neuropathic condition; medically stable and able to undergo surgery for implantation of the drug infusion system.

Primary outcomes:
measure: Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.
timeFrame: Baseline and Post-randomization Day 22
measure: Number of Participants With Treatment-emergent Adverse Events
timeFrame: Randomization to Post-randomization Day 29 (includes dose reduction)
Secondary outcomes:
measure: Responder Analysis Between Active Treatment and Placebo Groups.
timeFrame: Baseline to Post-randomization Day 22
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Innovative Spine Care
state: Arkansas
city: Napa
country: United States
facility: Napa Pain Institute
state: California
city: Sarasota
country: United States
facility: Sarasota Pain Medicine Research
state: Florida
city: Shreveport
country: United States
facility: WK River Cities Clinical Research Center
state: Louisiana
city: Edina
country: United States
facility: MAPS Applied Research Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Buffalo
country: United States
facility: U B Neurosurgery, Inc.
state: New York
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Eugene
country: United States
facility: Pain Research of Oregon, LLC
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University, Neurosurgery Department
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital Center for Pain Management
state: Pennsylvania
city: Dallas
country: United States
facility: Pinnacle Pain Medicine
state: Texas
city: Tyler
country: United States
facility: Axis Spine Care/Texas Spine & Joint
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
Study officials:
References:
citation: Rauck R, Coffey RJ, Schultz DM, Wallace MS, Webster LR, McCarville SE, Grigsby EJ, Page LM. Intrathecal gabapentin to treat chronic intractable noncancer pain. Anesthesiology. 2013 Sep;119(3):675-86. doi: 10.1097/ALN.0b013e3182a10fbf.