Clinical trial NCT00381095: A Study To Evaluate Pregabalin In The Treatment Of Moderate To Severe Chronic Bone Pain Related To Metastatic Cancer
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bone Neoplasms
Pain, Intractable
Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-27
Enrollment: 152
Sex: ALL
Minimum age (years): 18
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 assess the analgesic efficacy of flexibly-dosed pregabalin in the adjunctive treatment of subjects with cancer-induced bone pain.

Detailed description: Pfizer decided to discontinue additional enrollment into the study effective Sept 5 2010 after assessing the feasibility of completing this study in a realistic timeframe.The study was not stopped for any safety concerns.

Eligibility 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 reference 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.

Primary outcomes:
measure: Duration Adjusted Average Change (DAAC) From Baseline in Daily Worst Pain, Fixed Dosing Date to Day 28
timeFrame: Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET)
Secondary outcomes:
measure: DAAC From Baseline in Daily Worst Pain, Days 1 Through 28
timeFrame: Baseline, Days 1 through 28 or ET
measure: DAAC From Baseline in Daily Worst Pain, Day 1 to End of Dose Adjustment
timeFrame: Baseline, Day 1 to End of Dose Adjustment or ET
measure: DAAC From Baseline in Daily Worst Pain 14 Days After Fixed Dosing Date Up to Day 28
timeFrame: Baseline, 14 Days After Fixed Dosing Date up to Day 28 or ET
measure: Change From Baseline in Modified Brief Pain Inventory (mBPI-sf) Pain Severity Index Score at Week 4
timeFrame: Baseline, Week 4 or ET
measure: Change From Baseline in mBPI-sf Interference Index Score at Week 4
timeFrame: Baseline, Week 4 or ET
measure: Change From Baseline in Average Pain Scores at Weeks 1, 2, 3 and 4
timeFrame: Baseline, Weeks 1, 2, 3 and 4 or ET
measure: Change From Baseline in Total Daily Dose of Opioids Day 0 Through Day 28
timeFrame: Baseline, Day 0 through Day 28 or ET
measure: Change From Pre-Baseline in Total Daily Dose of Morphine Equivalents Day 0 Through Day 28
timeFrame: Baseline, Day 0 through Day 28 or ET
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 4
timeFrame: Baseline, Week 4 or ET
measure: Patient Global Impression of Change (PGIC)
timeFrame: Weeks 2 and 4 or ET
measure: Change From Baseline in Opioid-Related Symptoms Distress Scale (OR-SDS) at Day 14 and Day 28
timeFrame: Baseline, Day 14, Day 28 or ET
measure: Change From Baseline in Eastern Cooperative Oncology Group Performance (ECOG) Status Scale at Day 28
timeFrame: Baseline, Day 28 or ET
Other outcomes:
Locations:
city: Celebration
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pensacola
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pensacola
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Edina
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Canton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dover
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Benesov U Prahy
country: Czechia
facility: Pfizer Investigational Site
city: Horovice
country: Czechia
facility: Pfizer Investigational Site
city: Jablonec nad Nisou
country: Czechia
facility: Pfizer Investigational Site
city: Plzen
country: Czechia
facility: Pfizer Investigational Site
city: Praha 1 - Nove Mesto
country: Czechia
facility: Pfizer Investigational Site
city: Praha 6 - Hradcany
country: Czechia
facility: Pfizer Investigational Site
city: Cairo
country: Egypt
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Joensuu
country: Finland
facility: Pfizer Investigational Site
city: Bordeaux Cedex
country: France
facility: Pfizer Investigational Site
city: Villejuif
country: France
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Nyiregyhaza
country: Hungary
facility: Pfizer Investigational Site
city: Szentes
country: Hungary
facility: Pfizer Investigational Site
city: Tata
country: Hungary
facility: Pfizer Investigational Site
city: Aviano (PN)
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: México D.F
country: Mexico
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Bialystok
country: Poland
facility: Pfizer Investigational Site
city: Gdansk
country: Poland
facility: Pfizer Investigational Site
city: Kielce
country: Poland
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Vsevolozhsk
country: Russian Federation
facility: Pfizer Investigational Site
state: Vsevolozhsk District, Leningrad Region
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Alcorcon
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Lleida
country: Spain
facility: Pfizer Investigational Site
city: Orebro
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Kaohsiung Hsien
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung City
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Rachathewi
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Ratchathewi
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: Distrito Capital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Sjolund KF, Yang R, Lee KH, Resnick M. Randomized study of pregabalin in patients with cancer-induced bone pain. Pain Ther. 2013 Jun;2(1):37-48. doi: 10.1007/s40122-013-0009-8. Epub 2013 Feb 26.