NCT00354094

Brief Summary

The purpose of this study is to assess the long term (up to 2 years) safety and tolerability of \[S,S\]-Reboxetine in patients with pain after shingles.

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_2 pain

Timeline
Completed

Started Nov 2006

Geographic Reach
12 countries

40 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

November 8, 2007

Status Verified

November 1, 2007

First QC Date

July 18, 2006

Last Update Submit

November 7, 2007

Conditions

Pain

Outcome Measures

Primary Outcomes (5)

  • Vital signs

  • Physical examination

  • 12-lead ECG

  • Hematology/Biochemistry

  • Adverse events

Secondary Outcomes (8)

  • Pain Visual Analogue Scale

  • Patient Global Impression of Change

  • Neuropathic Pain Symptom Inventory

  • Modified Brief Pain Inventory - Short Form

  • SF-12 Health Survey

  • +3 more secondary outcomes

Interventions

[S,S]-ReboxetineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have pain present for more than 3 months after healing of the shingles skin rash.
  • Patients at screening must have a score of \>/=40mm on the pain visual analogue scale.

You may not qualify if:

  • Patients with significant hepatic impairment.
  • Patients with other severe pain, that may impair the self-assessment of pain due to postherpetic neuralgia (pain after shingles).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (40)

Pfizer Investigational Site

Tampa, Florida, 33606, United States

Location

Pfizer Investigational Site

West Palm Beach, Florida, 33407, United States

Location

Pfizer Investigational Site

Greensboro, North Carolina, 27401, United States

Location

Pfizer Investigational Site

Fargo, North Dakota, 58104, United States

Location

Pfizer Investigational Site

Cumberland, Rhode Island, 02864, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78213, United States

Location

Pfizer Investigational Site

Buenos Aires, Buenos Aires, C1280AEB, Argentina

Location

Pfizer Investigational Site

Buenos Aires, C1015ABR, Argentina

Location

Pfizer Investigational Site

Buenos Aires, C1133AAW, Argentina

Location

Pfizer Investigational Site

Buenos Aires, C1428AQK, Argentina

Location

Pfizer Investigational Site

Greater Sudbury, Ontario, P3A 1Y4, Canada

Location

Pfizer Investigational Site

Greater Sudbury, Ontario, P3A 1Y8, Canada

Location

Pfizer Investigational Site

Greater Sudbury, Ontario, P3E 1H5, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M3M 3E5, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3S 2W1, Canada

Location

Pfizer Investigational Site

Viña del Mar, Región de Valparaíso, 2520021, Chile

Location

Pfizer Investigational Site

Santiago, RM, Chile

Location

Pfizer Investigational Site

Split, 21000, Croatia

Location

Pfizer Investigational Site

Hyderabad, Andhra Pradhesh, 500 033, India

Location

Pfizer Investigational Site

Chandigarh, Punjab, 160 012, India

Location

Pfizer Investigational Site

Bangalore, 560 034, India

Location

Pfizer Investigational Site

Chennai, 600 116, India

Location

Pfizer Investigational Site

Hyderabad, 500 033, India

Location

Pfizer Investigational Site

New Delhi, 110 002, India

Location

Pfizer Investigational Site

New Delhi, 110 076, India

Location

Pfizer Investigational Site

Kaunas, 50009, Lithuania

Location

Pfizer Investigational Site

Klaipėda, 92304, Lithuania

Location

Pfizer Investigational Site

Panevezys, 35144, Lithuania

Location

Pfizer Investigational Site

Šiauliai, 76231, Lithuania

Location

Pfizer Investigational Site

Mérida, Yucatán, 97000, Mexico

Location

Pfizer Investigational Site

Sopot, 81-855, Poland

Location

Pfizer Investigational Site

Ourense, OURENSE, 32005, Spain

Location

Pfizer Investigational Site

Stockholm, S-141 86, Sweden

Location

Pfizer Investigational Site

Bexhill-on-Sea, East Sussex, TN40 1JJ, United Kingdom

Location

Pfizer Investigational Site

Addlestone, SURREY, KT15 2BH, United Kingdom

Location

Pfizer Investigational Site

Alcester, B49 5DZ, United Kingdom

Location

Pfizer Investigational Site

East Sussex, TN40 3RJ, United Kingdom

Location

Pfizer Investigational Site

London, EC1A 7BE, United Kingdom

Location

Pfizer Investigational Site

London, SW18 4DD, United Kingdom

Location

Pfizer Investigational Site

London, WC1X 8LD, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Pain

Interventions

O-methyl reboxetine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 18, 2006

First Posted

July 20, 2006

Study Start

November 1, 2006

Study Completion

October 1, 2007

Last Updated

November 8, 2007

Record last verified: 2007-11

Locations

PL(1)CA(5)GB(7)CL(2)LI(4)ME(1)IN(7)US(6)SE(1)ES(1)AR(4)CR(1)