[S,S]-Reboxetine Dose-Range Finding Trial
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00288652
Collaborator
(none)
280
79
11.1
3.5
0.3
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of different doses of [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
[S,S]-Reboxetine Dose-Range Finding Trial: A 16-Week, Randomized, Double-Blind, Placebo And An Active Comparator Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN)
Study Start Date
:
Mar 1, 2006
Actual Study Completion Date
:
Feb 1, 2007
Outcome Measures
Primary Outcome Measures
- The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 14 will be calculated []
Secondary Outcome Measures
- - The mean endpoint (week 14) sleep interference score change from baseline - Analysis of the Medical Outcomes Study Sleep Scale - Analysis of the Patient Global Impression of Change - Analysis of the SF-36 Health Survey []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients must have pain present for more than 3 months after the healing of shingles skin rash
-
Patients at screening must have a score >/=40 mm on the pain visual analogue scale
Exclusion Criteria:
-
Patients with significant renal and hepatic impairment
-
Patients with other severe pain, that may impair the self-assessment of the pain due to shingles
-
Patients with clinically abnormal electrocardiogram
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Huntsville | Alabama | United States | |
| 2 | Pfizer Investigational Site | Chandler | Arizona | United States | |
| 3 | Pfizer Investigational Site | Mesa | Arizona | United States | |
| 4 | Pfizer Investigational Site | Phoenix | Arizona | United States | |
| 5 | Pfizer Investigational Site | Sun City | Arizona | United States | |
| 6 | Pfizer Investigational Site | Tucson | Arizona | United States | |
| 7 | Pfizer Investigational Site | Hot Springs | Arkansas | United States | |
| 8 | Pfizer Investigational Site | Arcadia | California | United States | |
| 9 | Pfizer Investigational Site | Fullerton | California | United States | |
| 10 | Pfizer Investigational Site | Irvine | California | United States | |
| 11 | Pfizer Investigational Site | Laguna Hills | California | United States | |
| 12 | Pfizer Investigational Site | Loma Linda | California | United States | |
| 13 | Pfizer Investigational Site | Orange | California | United States | |
| 14 | Pfizer Investigational Site | Redondo Beach | California | United States | |
| 15 | Pfizer Investigational Site | Whittier | California | United States | |
| 16 | Pfizer Investigational Site | Boulder | Colorado | United States | |
| 17 | Pfizer Investigational Site | Bradenton | Florida | United States | |
| 18 | Pfizer Investigational Site | Clearwater | Florida | United States | |
| 19 | Pfizer Investigational Site | Ft. Myers | Florida | United States | |
| 20 | Pfizer Investigational Site | Holly Hill | Florida | United States | |
| 21 | Pfizer Investigational Site | Hollywood | Florida | United States | |
| 22 | Pfizer Investigational Site | Kissimmee | Florida | United States | |
| 23 | Pfizer Investigational Site | Largo | Florida | United States | |
| 24 | Pfizer Investigational Site | Longwood | Florida | United States | |
| 25 | Pfizer Investigational Site | Melbourne | Florida | United States | |
| 26 | Pfizer Investigational Site | Ocala | Florida | United States | |
| 27 | Pfizer Investigational Site | Oviedo | Florida | United States | |
| 28 | Pfizer Investigational Site | Palm Beach Gardens | Florida | United States | |
| 29 | Pfizer Investigational Site | Plantation | Florida | United States | |
| 30 | Pfizer Investigational Site | Chicago | Illinois | United States | |
| 31 | Pfizer Investigational Site | Oak Brook | Illinois | United States | |
| 32 | Pfizer Investigational Site | Evansville | Indiana | United States | |
| 33 | Pfizer Investigational Site | Topeka | Kansas | United States | |
| 34 | Pfizer Investigational Site | Ruston | Louisiana | United States | |
| 35 | Pfizer Investigational Site | Towson | Maryland | United States | |
| 36 | Pfizer Investigational Site | Boston | Massachusetts | United States | |
| 37 | Pfizer Investigational Site | Brockton | Massachusetts | United States | |
| 38 | Pfizer Investigational Site | Ann Arbor | Michigan | United States | |
| 39 | Pfizer Investigational Site | Southaven | Mississippi | United States | |
| 40 | Pfizer Investigational Site | Independence | Missouri | United States | |
| 41 | Pfizer Investigational Site | Kansas City | Missouri | United States | |
| 42 | Pfizer Investigational Site | Nixa | Missouri | United States | |
| 43 | Pfizer Investigational Site | Sprinfield | Missouri | United States | |
| 44 | Pfizer Investigational Site | St. Louis | Missouri | United States | |
| 45 | Pfizer Investigational Site | Billings | Montana | United States | |
| 46 | Pfizer Investigational Site | Clifton | New Jersey | United States | |
| 47 | Pfizer Investigational Site | Hackensack | New Jersey | United States | |
| 48 | Pfizer Investigational Site | Teaneck | New Jersey | United States | |
| 49 | Pfizer Investigational Site | Sante Fe | New Mexico | United States | |
| 50 | Pfizer Investigational Site | Albany | New York | United States | |
| 51 | Pfizer Investigational Site | Amherst | New York | United States | |
| 52 | Pfizer Investigational Site | New York | New York | United States | |
| 53 | Pfizer Investigational Site | Orchard Park | New York | United States | |
| 54 | Pfizer Investigational Site | Rochester | New York | United States | |
| 55 | Pfizer Investigational Site | Asheville | North Carolina | United States | |
| 56 | Pfizer Investigational Site | Raleigh | North Carolina | United States | |
| 57 | Pfizer Investigational Site | Winston-Salem | North Carolina | United States | |
| 58 | Pfizer Investigational Site | Fargo | North Dakota | United States | |
| 59 | Pfizer Investigational Site | Canfield | Ohio | United States | |
| 60 | Pfizer Investigational Site | Cincinnati | Ohio | United States | |
| 61 | Pfizer Investigational Site | Cleveland | Ohio | United States | |
| 62 | Pfizer Investigational Site | Columbus | Ohio | United States | |
| 63 | Pfizer Investigational Site | Kettering | Ohio | United States | |
| 64 | Pfizer Investigational Site | Toledo | Ohio | United States | |
| 65 | Pfizer Investigational Site | Oklahoma City | Oklahoma | United States | |
| 66 | Pfizer Investigational Site | Allentown | Pennsylvania | United States | |
| 67 | Pfizer Investigational Site | Altoona | Pennsylvania | United States | |
| 68 | Pfizer Investigational Site | Duncansville | Pennsylvania | United States | |
| 69 | Pfizer Investigational Site | Jackson | Tennessee | United States | |
| 70 | Pfizer Investigational Site | Kingsport | Tennessee | United States | |
| 71 | Pfizer Investigational Site | Austin | Texas | United States | |
| 72 | Pfizer Investigational Site | Dallas | Texas | United States | |
| 73 | Pfizer Investigational Site | Houston | Texas | United States | |
| 74 | Pfizer Investigational Site | San Antonio | Texas | United States | |
| 75 | Pfizer Investigational Site | Norfolk | Virginia | United States | |
| 76 | Pfizer Investigational Site | Richmond | Virginia | United States | |
| 77 | Pfizer Investigational Site | Seattle | Washington | United States | |
| 78 | Pfizer Investigational Site | Spokane | Washington | United States | |
| 79 | Pfizer Investigational Site | Tacoma | Washington | United States |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00288652
Other Study ID Numbers:
- A6061026
First Posted:
Feb 8, 2006
Last Update Posted:
Jun 8, 2011
Last Verified:
Jun 1, 2011
Additional relevant MeSH terms: