ClinicalTrials.gov record
Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
ClinicalTrials.gov ID: NCT00516503
Public ClinicalTrials.gov record NCT00516503. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Use of Topical Baclofen, Amitriptyline HCI, and Ketamine (BAK) in a PLO Gel vs. Placebo for the Treatment of Chemotherapy Induced Peripheral Neuropathy: A Phase III Randomized Double-Blind Placebo Controlled Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
RATIONALE: Baclofen-amitriptyline-ketamine (BAK) gel may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether BAK gel is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy . PURPOSE: This randomized phase III trial is studying BAK gel to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.
Study identification
- NCT ID
- NCT00516503
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 208 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2008 (Type not available)
- Primary completion
- Apr 2009 (Actual)
- Completion
- Jan 2010 (Actual)
- Last update posted
- Aug 24, 2017
2008 – 2010
United States locations
- U.S. sites
- 165
- U.S. states
- 19
- U.S. cities
- 107
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | — |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | — |
| Rush-Copley Cancer Care Center | Aurora | Illinois | 60504 | — |
| St. Joseph Medical Center | Bloomington | Illinois | 61701 | — |
| Graham Hospital | Canton | Illinois | 61520 | — |
| Memorial Hospital | Carthage | Illinois | 62321 | — |
| Eureka Community Hospital | Eureka | Illinois | 61530 | — |
| Galesburg Clinic, PC | Galesburg | Illinois | 61401 | — |
| Galesburg Cottage Hospital | Galesburg | Illinois | 61401 | — |
| Mason District Hospital | Havana | Illinois | 62644 | — |
| Hopedale Medical Complex | Hopedale | Illinois | 61747 | — |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | 60435 | — |
| McDonough District Hospital | Macomb | Illinois | 61455 | — |
| Not listed | Moline | Illinois | 61265 | — |
| Community Cancer Center | Normal | Illinois | 61761 | — |
| Community Hospital of Ottawa | Ottawa | Illinois | 61350 | — |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois | 61350 | — |
| Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | 61554 | — |
| Proctor Hospital | Peoria | Illinois | 61614 | — |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61615 | — |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | 61615 | — |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | — |
| OSF St. Francis Medical Center | Peoria | Illinois | 61637 | — |
| Illinois Valley Community Hospital | Peru | Illinois | 61354 | — |
| Perry Memorial Hospital | Princeton | Illinois | 61356 | — |
| St. Margaret's Hospital | Spring Valley | Illinois | 61362 | — |
| Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | 61801 | — |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | — |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | — |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | — |
| Howard Community Hospital | Kokomo | Indiana | 46904 | — |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | 46350 | — |
| Saint Anthony Memorial Health Centers | Michigan City | Indiana | 46360 | — |
| Reid Hospital & Health Care Services | Richmond | Indiana | 47374 | — |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | — |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | — |
| Saint Joseph Regional Medical Center | South Bend | Indiana | 46617 | — |
| McFarland Clinic, PC | Ames | Iowa | 50010 | — |
| Not listed | Bettendorf | Iowa | 52722 | — |
| Cedar Rapids Oncology Associates | Cedar Rapids | Iowa | 52403 | — |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101 | — |
| Mercy Medical Center - Sioux City | Sioux City | Iowa | 51104 | — |
| St. Luke's Regional Medical Center | Sioux City | Iowa | 51104 | — |
| Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | 49221 | — |
| Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville | Michigan | 48144 | — |
| Community Cancer Center of Monroe | Monroe | Michigan | 48162 | — |
| Mercy Memorial Hospital - Monroe | Monroe | Michigan | 48162 | — |
| Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan | 49085 | — |
| MeritCare Bemidji | Bemidji | Minnesota | 56601 | — |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | — |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | 55433 | — |
| Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota | 55805-1983 | — |
| CCOP - Duluth | Duluth | Minnesota | 55805 | — |
| Miller - Dwan Medical Center | Duluth | Minnesota | 55805 | — |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | — |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | 55432 | — |
| Immanuel St. Joseph's | Mankato | Minnesota | 56002 | — |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | 55109 | — |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | 55422-2900 | — |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | — |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | — |
| Park Nicollet Cancer Center | Saint Louis Park | Minnesota | 55416 | — |
| United Hospital | Saint Paul | Minnesota | 55102 | — |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | — |
| Willmar Cancer Center at Rice Memorial Hospital | Willmar | Minnesota | 56201 | — |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | 55125 | — |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | — |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | 59101 | — |
| Northern Rockies Radiation Oncology Center | Billings | Montana | 59101 | — |
| St. Vincent Healthcare Cancer Care Services | Billings | Montana | 59101 | — |
| Billings Clinic - Downtown | Billings | Montana | 59107-7000 | — |
| St. James Healthcare Cancer Care | Butte | Montana | 59701 | — |
| Big Sky Oncology | Great Falls | Montana | 59405-5309 | — |
| Great Falls Clinic - Main Facility | Great Falls | Montana | 59405 | — |
| Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana | 59405 | — |
| Not listed | Great Falls | Montana | 59405 | — |
| Glacier Oncology, PLLC | Kalispell | Montana | 59901 | — |
| Kalispell Medical Oncology at KRMC | Kalispell | Montana | 59901 | — |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | — |
| Community Medical Center | Missoula | Montana | 59801 | — |
| Guardian Oncology and Center for Wellness | Missoula | Montana | 59804 | — |
| Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | 59807-7877 | — |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | 59807 | — |
| Cancer Resource Center - Lincoln | Lincoln | Nebraska | 68510 | — |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | — |
| Immanuel Medical Center | Omaha | Nebraska | 68122 | — |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska | 68124 | — |
| Creighton University Medical Center | Omaha | Nebraska | 68131-2197 | — |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | — |
| Bismarck Cancer Center | Bismarck | North Dakota | 58501 | — |
| Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota | 58501 | — |
| Mid Dakota Clinic, PC | Bismarck | North Dakota | 58501 | — |
| St. Alexius Medical Center Cancer Center | Bismarck | North Dakota | 58502 | — |
| CCOP - MeritCare Hospital | Fargo | North Dakota | 58122 | — |
| MeritCare Broadway | Fargo | North Dakota | 58122 | — |
| Altru Cancer Center at Altru Hospital | Grand Forks | North Dakota | 58201 | — |
| Mary Rutan Hospital | Bellefontaine | Ohio | 43311 | — |
| Wood County Oncology Center | Bowling Green | Ohio | 43402 | — |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | — |
| North Coast Cancer Care - Clyde | Clyde | Ohio | 43410 | — |
| Riverside Methodist Hospital Cancer Care | Columbus | Ohio | 43214-3998 | — |
| CCOP - Columbus | Columbus | Ohio | 43215 | — |
| Grant Medical Center Cancer Care | Columbus | Ohio | 43215 | — |
| Mount Carmel Health - West Hospital | Columbus | Ohio | 43222 | — |
| Doctors Hospital at Ohio Health | Columbus | Ohio | 43228 | — |
| Grandview Hospital | Dayton | Ohio | 45405 | — |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | — |
| Samaritan North Cancer Care Center | Dayton | Ohio | 45415 | — |
| CCOP - Dayton | Dayton | Ohio | 45429 | — |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | — |
| Hematology Oncology Center | Elyria | Ohio | 44035 | — |
| Blanchard Valley Medical Associates | Findlay | Ohio | 45840 | — |
| Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | — |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | — |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | — |
| Lima Memorial Hospital | Lima | Ohio | 45804 | — |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | 45750 | — |
| Northwest Ohio Oncology Center | Maumee | Ohio | 43537 | — |
| St. Luke's Hospital | Maumee | Ohio | 43537 | — |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | 43055 | — |
| St. Charles Mercy Hospital | Oregon | Ohio | 43616 | — |
| Toledo Clinic - Oregon | Oregon | Ohio | 43616 | — |
| North Coast Cancer Care, Incorporated | Sandusky | Ohio | 44870 | — |
| Mercy Medical Center | Springfield | Ohio | 45504 | — |
| Community Hospital of Springfield and Clark County | Springfield | Ohio | 45505 | — |
| Flower Hospital Cancer Center | Sylvania | Ohio | 43560 | — |
| Mercy Hospital of Tiffin | Tiffin | Ohio | 44883 | — |
| Toledo Hospital | Toledo | Ohio | 43606 | — |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | — |
| Medical University of Ohio Cancer Center | Toledo | Ohio | 43614 | — |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43617 | — |
| St. Anne Mercy Hospital | Toledo | Ohio | 43623 | — |
| Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio | 43623 | — |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | — |
| Fulton County Health Center | Wauseon | Ohio | 43567 | — |
| Mount Carmel St. Ann's Cancer Center | Westerville | Ohio | 43081 | — |
| Clinton Memorial Hospital | Wilmington | Ohio | 45177 | — |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | — |
| Genesis - Good Samaritan Hospital | Zanesville | Ohio | 43701 | — |
| Legacy Mount Hood Medical Center | Gresham | Oregon | 97030 | — |
| Providence Milwaukie Hospital | Milwaukie | Oregon | 97222 | — |
| Legacy Good Samaritan Hospital & Comprehensive Cancer Center | Portland | Oregon | 97210 | — |
| Providence Cancer Center at Providence Portland Medical Center | Portland | Oregon | 97213-2967 | — |
| Adventist Medical Center | Portland | Oregon | 97216 | — |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | — |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | — |
| Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland | Oregon | 97227 | — |
| Legacy Meridian Park Hospital | Tualatin | Oregon | 97062 | — |
| Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | 17822-0001 | — |
| Geisinger Hazleton Cancer Center | Hazleton | Pennsylvania | 18201 | — |
| Guthrie Cancer Center at Guthrie Clinic Sayre | Sayre | Pennsylvania | 18840 | — |
| Geisinger Medical Group - Scenery Park | State College | Pennsylvania | 16801 | — |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | — |
| Mercy Hospital at Wilkes-Barre | Wilkes-Barre | Pennsylvania | 18765 | — |
| AnMed Cancer Center | Anderson | South Carolina | 29621 | — |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | — |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | — |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | — |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | — |
| Medical X-Ray Center, PC | Sioux Falls | South Dakota | 57105 | — |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | — |
| Fredericksburg Oncology, Incorporated | Fredericksburg | Virginia | 22401 | — |
| Southwest Washington Medical Center Cancer Center | Vancouver | Washington | 98668 | — |
| Franciscan Skemp Healthcare - La Crosse Campus | La Crosse | Wisconsin | 54601 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00516503, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 24, 2017 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00516503 live on ClinicalTrials.gov.