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

Primary Purpose

Bone Neoplasms, Pain, Intractable, Cancer

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Pregabalin
Placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

flexible dosing

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.

Full Information

First Posted
September 25, 2006
Last Updated
January 15, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00381095
Brief Title
A Study To Evaluate Pregabalin In The Treatment Of Moderate To Severe Chronic Bone Pain Related To Metastatic Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
December 2006 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Neoplasms, Pain, Intractable, Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
flexible dosing
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Capsule, Flexible-dosing, Double-blind. Treatment duration is 28 days at 100-600 mg/day administered BID+ taper (6 days).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Duration Adjusted Average Change (DAAC) From Baseline in Daily Worst Pain, Fixed Dosing Date to Day 28
Description
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.
Time Frame
Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET)
Secondary Outcome Measure Information:
Title
DAAC From Baseline in Daily Worst Pain, Days 1 Through 28
Description
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.
Time Frame
Baseline, Days 1 through 28 or ET
Title
DAAC From Baseline in Daily Worst Pain, Day 1 to End of Dose Adjustment
Description
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.
Time Frame
Baseline, Day 1 to End of Dose Adjustment or ET
Title
DAAC From Baseline in Daily Worst Pain 14 Days After Fixed Dosing Date Up to Day 28
Description
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.
Time Frame
Baseline, 14 Days After Fixed Dosing Date up to Day 28 or ET
Title
Change From Baseline in Modified Brief Pain Inventory (mBPI-sf) Pain Severity Index Score at Week 4
Description
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.
Time Frame
Baseline, Week 4 or ET
Title
Change From Baseline in mBPI-sf Interference Index Score at Week 4
Description
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.
Time Frame
Baseline, Week 4 or ET
Title
Change From Baseline in Average Pain Scores at Weeks 1, 2, 3 and 4
Description
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.
Time Frame
Baseline, Weeks 1, 2, 3 and 4 or ET
Title
Change From Baseline in Total Daily Dose of Opioids Day 0 Through Day 28
Description
Change from baseline in total daily dose of opioids immediate release (IR), sustained release (SR) formulations separately and combined.
Time Frame
Baseline, Day 0 through Day 28 or ET
Title
Change From Pre-Baseline in Total Daily Dose of Morphine Equivalents Day 0 Through Day 28
Description
IR and SR formulations separately and combined. Change was day x minus baseline.
Time Frame
Baseline, Day 0 through Day 28 or ET
Title
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 4
Description
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.
Time Frame
Baseline, Week 4 or ET
Title
Patient Global Impression of Change (PGIC)
Description
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).
Time Frame
Weeks 2 and 4 or ET
Title
Change From Baseline in Opioid-Related Symptoms Distress Scale (OR-SDS) at Day 14 and Day 28
Description
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.
Time Frame
Baseline, Day 14, Day 28 or ET
Title
Change From Baseline in Eastern Cooperative Oncology Group Performance (ECOG) Status Scale at Day 28
Description
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.
Time Frame
Baseline, Day 28 or ET

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747
Country
United States
Facility Name
Pfizer Investigational Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Pfizer Investigational Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Pfizer Investigational Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
Pfizer Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Pfizer Investigational Site
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Pfizer Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Pfizer Investigational Site
City
Dover
State/Province
Ohio
ZIP/Postal Code
44622
Country
United States
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Benesov U Prahy
ZIP/Postal Code
256 30
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Horovice
ZIP/Postal Code
268 31
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Jablonec nad Nisou
ZIP/Postal Code
466 60
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Plzen
ZIP/Postal Code
301 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 1 - Nove Mesto
ZIP/Postal Code
110 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 6 - Hradcany
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Facility Name
Pfizer Investigational Site
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Pfizer Investigational Site
City
Joensuu
ZIP/Postal Code
80210
Country
Finland
Facility Name
Pfizer Investigational Site
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Pfizer Investigational Site
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Tata
ZIP/Postal Code
2890
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Aviano (PN)
ZIP/Postal Code
33081
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Pfizer Investigational Site
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
064460
Country
Mexico
Facility Name
Pfizer Investigational Site
City
México D.F
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
L-41
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
L13
Country
Peru
Facility Name
Pfizer Investigational Site
City
Manila
ZIP/Postal Code
1015
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Bialystok
ZIP/Postal Code
15-748
Country
Poland
Facility Name
Pfizer Investigational Site
City
Gdansk
ZIP/Postal Code
80-208
Country
Poland
Facility Name
Pfizer Investigational Site
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Facility Name
Pfizer Investigational Site
City
Lodz
ZIP/Postal Code
90-251
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Pfizer Investigational Site
City
Vsevolozhsk
State/Province
Vsevolozhsk District, Leningrad Region
ZIP/Postal Code
188640
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Pfizer Investigational Site
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Pfizer Investigational Site
City
Orebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Kaohsiung Hsien
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taichung City
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Rachathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Caracas
State/Province
Distrito Capital
ZIP/Postal Code
1010
Country
Venezuela

12. IPD Sharing Statement

Citations:
PubMed Identifier
25135035
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081128&StudyName=A%20Study%20To%20Evaluate%20Pregabalin%20In%20The%20Treatment%20Of%20Moderate%20To%20Severe%20Chronic%20Bone%20Pain%20Related%20To%20Metastatic%20Cancer
Description
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A Study To Evaluate Pregabalin In The Treatment Of Moderate To Severe Chronic Bone Pain Related To Metastatic Cancer

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