A Study To Evaluate Pregabalin In The Treatment Of Moderate To Severe Chronic Bone Pain Related To Metastatic Cancer

Condition(s) targeted: Bone Neoplasms; Pain, Intractable; Cancer

Intervention: Pregabalin (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

The purpose of this study is to assess the analgesic efficacy of flexibly-dosed pregabalin in the adjunctive treatment of subjects with cancer-induced bone pain.

Official title: A Randomized Placebo-Controlled Trial Of The Efficacy And Tolerability Of Flexibly Dosed Pregabalin In The Treatment Of Cancer-Induced Bone Pain

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Duration adjusted average change (DAAC) ifrom baseline in the daily worst pain on Numeric Rating Scale score during the fixed dose period.

Secondary outcome:

Change from baseline in Opioi-Related Symptom Distress Scale

Patient Global Impression of Change

Duration adjusted average change (DAAC)in daily worst pain for the double-blind treatment period, flexible dose period, and 2 weeks after reaching stable treatment dose

Change from baseline in Eastern Cooperative Oncology Gruop Performance Status Scale

Adverse event reporting

SAEs

Change from baseline in the modified Brief Pain Inventory -short form (mBPI-sf) worst/least/average/current pain scores

Change from baseline in mBPI-sf interference with various daily activities

Change from baseline in subject daily diary reported worst/average sleep pain scores

Change from baseline in total daily dose of opioids IR and SR formulations combined and separately

Change from baseline in Hospital Anxiety and Depression subscale scores for anxiety, depression, and for individual symptoms

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient must have a malignant, solid tumor that has been diagnosed as having

metastasized to bone, and must have moderate to severe pain secondary to the bone metastasis at an identifiable refernce site.

Exclusion Criteria:

- The patient who has undergone diagnostic or therapeutic invasive interventions

(angiography, biopsy, surgery) less than 15 days prior to study start that would impact their assessment of pain at the reference pain site or area, in the opinion of the investigator.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Cairo 11796, Egypt; Recruiting

Pfizer Investigational Site, Helsinki 00029, Finland; Active, not recruiting

Pfizer Investigational Site, Joensuu 80210, Finland; Active, not recruiting

Pfizer Investigational Site, Villejuif 94805, France; Not yet recruiting

Pfizer Investigational Site, Poitiers 86021, France; Not yet recruiting

Pfizer Investigational Site, Milano 20133, Italy; Recruiting

Pfizer Investigational Site, Rionero in Vulture (PZ) 85028, Italy; Not yet recruiting

Pfizer Investigational Site, Aviano (PN) 33081, Italy; Active, not recruiting

Pfizer Investigational Site, Seoul 110-744, Korea, Republic of; Active, not recruiting

Pfizer Investigational Site, Seoul 152-703, Korea, Republic of; Recruiting

Pfizer Investigational Site, Daegu 705-717, Korea, Republic of; Recruiting

Pfizer Investigational Site, México D.F 14080, Mexico; Active, not recruiting

Pfizer Investigational Site, LLEIDA 25198, Spain; Active, not recruiting

Pfizer Investigational Site, Stockholm 171 76, Sweden; Active, not recruiting

Pfizer Investigational Site, Orebro 701 85, Sweden; Completed

Pfizer Investigational Site, Kaohsiung Hsien 833, Taiwan; Recruiting

Pfizer Investigational Site, Taichung City 40705, Taiwan; Recruiting

Pfizer Investigational Site, Taipei 100, Taiwan; Not yet recruiting

Pfizer Investigational Site, Birmingham, Alabama 35233, United States; Recruiting

Pfizer Investigational Site, Victoria, British Columbia V8R 1J8, Canada; Not yet recruiting

Pfizer Investigational Site, ALCORCON, MADRID 28922, Spain; Active, not recruiting

Pfizer Investigational Site, Durham, North Carolina 27710, United States; Not yet recruiting

Pfizer Investigational Site, Monterrey, Nuevo Leon 64460, Mexico; Active, not recruiting

Pfizer Investigational Site, London, Ontario N6A 4G5, Canada; Not yet recruiting

Pfizer Investigational Site, London, Ontario N6A 4L6, Canada; Not yet recruiting

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15232, United States; Not yet recruiting

To obtain contact information for a study center near you, click here.

Starting date: December 2006
Ending date: October 2010
Last updated: October 27, 2008