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

Cancer Clinical Trial

— COPE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00381095
• Other study ID #: A0081128
• Status: Terminated
• Phase: Phase 4
• Start date: December 2006
• Est. completion date: October 2010

Study information

• Verified date: April 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 152
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Neoplasms
• Cancer
• Pain, Intractable

Intervention

Drug:
• Pregabalin
Capsule, Flexible-dosing, Double-blind. Treatment duration is 28 days at 100-600 mg/day administered BID+ taper (6 days).
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Hamilton	Ontario
Czechia	Pfizer Investigational Site	Benesov U Prahy
Czechia	Pfizer Investigational Site	Horovice
Czechia	Pfizer Investigational Site	Jablonec nad Nisou
Czechia	Pfizer Investigational Site	Plzen
Czechia	Pfizer Investigational Site	Praha 1 - Nove Mesto
Czechia	Pfizer Investigational Site	Praha 6 - Hradcany
Egypt	Pfizer Investigational Site	Cairo
Finland	Pfizer Investigational Site	Helsinki
Finland	Pfizer Investigational Site	Joensuu
France	Pfizer Investigational Site	Bordeaux Cedex
France	Pfizer Investigational Site	Villejuif
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Nyiregyhaza
Hungary	Pfizer Investigational Site	Szentes
Hungary	Pfizer Investigational Site	Tata
Italy	Pfizer Investigational Site	Aviano (PN)
Italy	Pfizer Investigational Site	Milano
Korea, Republic of	Pfizer Investigational Site	Daegu
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Mexico	Pfizer Investigational Site	México D.F
Mexico	Pfizer Investigational Site	Monterrey	Nuevo Leon
Peru	Pfizer Investigational Site	Lima
Peru	Pfizer Investigational Site	Lima
Philippines	Pfizer Investigational Site	Manila
Philippines	Pfizer Investigational Site	Quezon City
Poland	Pfizer Investigational Site	Bialystok
Poland	Pfizer Investigational Site	Gdansk
Poland	Pfizer Investigational Site	Kielce
Poland	Pfizer Investigational Site	Lodz
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Warszawa
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Saint-Petersburg
Russian Federation	Pfizer Investigational Site	Vsevolozhsk	Vsevolozhsk District, Leningrad Region
Spain	Pfizer Investigational Site	Alcorcon	Madrid
Spain	Pfizer Investigational Site	Lleida
Sweden	Pfizer Investigational Site	Orebro
Sweden	Pfizer Investigational Site	Stockholm
Taiwan	Pfizer Investigational Site	Kaohsiung Hsien
Taiwan	Pfizer Investigational Site	Taichung City
Taiwan	Pfizer Investigational Site	Taipei
Thailand	Pfizer Investigational Site	Rachathewi	Bangkok
Thailand	Pfizer Investigational Site	Ratchathewi	Bangkok
United States	Pfizer Investigational Site	Canton	Ohio
United States	Pfizer Investigational Site	Celebration	Florida
United States	Pfizer Investigational Site	Dover	Ohio
United States	Pfizer Investigational Site	Edina	Minnesota
United States	Pfizer Investigational Site	Kissimmee	Florida
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Pensacola	Florida
United States	Pfizer Investigational Site	Pensacola	Florida
Venezuela	Pfizer Investigational Site	Caracas	Distrito Capital

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Venezuela,  Canada,  Czechia,  Egypt,  Finland,  France,  Hungary,  Italy,  Korea, Republic of,  Mexico,  Peru,  Philippines,  Poland,  Russian Federation,  Spain,  Sweden,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration Adjusted Average Change (DAAC) From Baseline in Daily Worst Pain, Fixed Dosing Date to Day 28	DAAC from baseline based on Numeric Rating Scale (NRS) score for Worst Pain at Reference site from the last day dose adjustment was needed (fixed dosing date) to day 28. DAAC defined as area under the curve (AUC) of change in worst pain divided by pain measurement duration. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). Change was week x minus baseline.	Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET)
Secondary	DAAC From Baseline in Daily Worst Pain, Days 1 Through 28	DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant's daily diary. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.	Baseline, Days 1 through 28 or ET
Secondary	DAAC From Baseline in Daily Worst Pain, Day 1 to End of Dose Adjustment	DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant's daily diary. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.	Baseline, Day 1 to End of Dose Adjustment or ET
Secondary	DAAC From Baseline in Daily Worst Pain 14 Days After Fixed Dosing Date Up to Day 28	DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant's daily diary 14 days after dosing stabilized (fixed dosing date) up to Day 28. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.	Baseline, 14 Days After Fixed Dosing Date up to Day 28 or ET
Secondary	Change From Baseline in Modified Brief Pain Inventory (mBPI-sf) Pain Severity Index Score at Week 4	m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index was the mean of item scores 1, 2, 3, and 4 (worst, least, average and current pain scores). Change was scores at observation minus scores at baseline.	Baseline, Week 4 or ET
Secondary	Change From Baseline in mBPI-sf Interference Index Score at Week 4	m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely intereres) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Change was score at each observation minus baseline score.	Baseline, Week 4 or ET
Secondary	Change From Baseline in Average Pain Scores at Weeks 1, 2, 3 and 4	Change from baseline in daily average pain score NRS 0 (no pain) to 10 (pain as bad as you can imagine) for pain intensity over past 24 hours recorded every evening before bedtime. Change was week x average minus baseline average.	Baseline, Weeks 1, 2, 3 and 4 or ET
Secondary	Change From Baseline in Total Daily Dose of Opioids Day 0 Through Day 28	Change from baseline in total daily dose of opioids immediate release (IR), sustained release (SR) formulations separately and combined.	Baseline, Day 0 through Day 28 or ET
Secondary	Change From Pre-Baseline in Total Daily Dose of Morphine Equivalents Day 0 Through Day 28	IR and SR formulations separately and combined. Change was day x minus baseline.	Baseline, Day 0 through Day 28 or ET
Secondary	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 4	HADS: participant rated questionnaire with 2 subscales. HADS-Anxiety assessed generalized anxiety (anxious mood/ restlessness/ anxious thoughts/panic attacks); HADS-Depression assessed lost interest/diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items which ranged from 0 (no presence of anxiety or depression) to 3 (severe feeling anxiety/depression). Total 0-21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. Change was week x minus baseline.	Baseline, Week 4 or ET
Secondary	Patient Global Impression of Change (PGIC)	PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).	Weeks 2 and 4 or ET
Secondary	Change From Baseline in Opioid-Related Symptoms Distress Scale (OR-SDS) at Day 14 and Day 28	OR-SDS included OR-SDS individual items by dimension of frequency (rarely to almost constantly), severity (slight to very severe), and degree of bother (not at all to very much), number of episodes of retching/vomiting, OR-SDS dimension composite and overall composite scores. Change was scores at occurance minus score at baseline.	Baseline, Day 14, Day 28 or ET
Secondary	Change From Baseline in Eastern Cooperative Oncology Group Performance (ECOG) Status Scale at Day 28	ECOG - assessed disease progression and how disease affected the daily living abilities of the participant and determined appropriate treatment and prognosis. Graded 0 (fully active able to carry on all pre-disease performance without restrictions) to 5 (dead). Change was day 28 minus baseline.	Baseline, Day 28 or ET

External Links

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