Bone NeoplasmsPhase 4COPENCT00381095
A Study To Evaluate Pregabalin In The Treatment Of Moderate To Severe Chronic Bone Pain Related To Metastatic Cancer
A Phase 4 study testing Pregabalin in people with Bone Neoplasms and Pain, Intractable, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 55 sites in 19 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Neoplasms, Pain, Intractable, Cancer
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 55 sitesin 19 countries
- Study dates
- Dec 2006to Oct 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
55 sites in 19 countries.
55 sites in 19 countries
United States8 sites
Pfizer Investigational Site
Canton, Ohio, 44718
Pfizer Investigational Site
Celebration, Florida, 34747
Pfizer Investigational Site
Dover, Ohio, 44622
Pfizer Investigational Site
Edina, Minnesota, 55435
Pfizer Investigational Site
Kissimmee, Florida, 34741
Pfizer Investigational Site
Louisville, Kentucky, 40202
Pfizer Investigational Site
Pensacola, Florida, 32504
Pfizer Investigational Site
Pensacola, Florida, 32514
Czechia6 sites
Pfizer Investigational Site
Benesov U Prahy, 256 30
Pfizer Investigational Site
Hořovice, 268 31
Pfizer Investigational Site
Jablonec nad Nisou, 466 60
Pfizer Investigational Site
Pilsen, 301 00
Pfizer Investigational Site
Praha 1 - Nove Mesto, 110 00
Pfizer Investigational Site
Praha 6 - Hradcany, 160 00
Poland6 sites
Pfizer Investigational Site
Bialystok, 15-748
Pfizer Investigational Site
Gdansk, 80-208
Pfizer Investigational Site
Kielce, 25-734
Pfizer Investigational Site
Lodz, 90-251
Pfizer Investigational Site
Warsaw, 00-909
Pfizer Investigational Site
Warsaw, 02-781
Hungary5 sites
Pfizer Investigational Site
Budapest, 1106
Pfizer Investigational Site
Budapest, 1125
Pfizer Investigational Site
Nyíregyháza, 4400
Pfizer Investigational Site
Szentes, 6600
Pfizer Investigational Site
Tata, 2890
Russia3 sites
Pfizer Investigational Site
Moscow, 125284
Pfizer Investigational Site
Saint Petersburg, 197089
Pfizer Investigational Site
Vsevolozhsk, Vsevolozhsk District, Leningrad Region, 188640
South Korea3 sites
Pfizer Investigational Site
Daegu, 705-717
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 152-703
Taiwan3 sites
Pfizer Investigational Site
Kaohsiung Hsien, 833
Pfizer Investigational Site
Taichung, 40705
Pfizer Investigational Site
Taipei, 100
Finland2 sites
Pfizer Investigational Site
Helsinki, 00029
Pfizer Investigational Site
Joensuu, 80210
France2 sites
Pfizer Investigational Site
Bordeaux, 33076
Pfizer Investigational Site
Villejuif, 94805
Italy2 sites
Pfizer Investigational Site
Aviano (PN), 33081
Pfizer Investigational Site
Milan, 20133
Mexico2 sites
Pfizer Investigational Site
México D.F, 14080
Pfizer Investigational Site
Monterrey, Nuevo León, 064460
Peru2 sites
Pfizer Investigational Site
Lima, L-41
Pfizer Investigational Site
Lima, L13
Philippines2 sites
Pfizer Investigational Site
Manila, 1015
Pfizer Investigational Site
Quezon City, 1102
Spain2 sites
Pfizer Investigational Site
Alcorcón, Madrid, 28922
Pfizer Investigational Site
Lleida, 25198
Sweden2 sites
Pfizer Investigational Site
Örebro, 701 85
Pfizer Investigational Site
Stockholm, 171 76
Thailand2 sites
Pfizer Investigational Site
Rachathewi, Bangkok, 10400
Pfizer Investigational Site
Ratchathewi, Bangkok, 10400
About this study
Official title: A Randomized Placebo-Controlled Trial Of The Efficacy And Tolerability Of Flexibly Dosed Pregabalin In The Treatment Of Cancer-Induced Bone Pain
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.
Read the 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.
- Conditions
- Bone Neoplasms, Pain, Intractable, Cancer
- Being tested
- Pregabalin, Placebo
- Medical subject headings
- Bone Neoplasms, Pain, Intractable, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Capsule, Flexible-dosing, Double-blind. Treatment duration is 28 days at 100-600 mg/day administered BID+ taper (6 days).
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | flexible dosing Receives: Drug: Pregabalin |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET)
Secondary outcomes (12)
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.
Measured: Baseline, Days 1 through 28 or ET
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.
Measured: Baseline, Day 1 to End of Dose Adjustment or ET
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.
Measured: Baseline, 14 Days After Fixed Dosing Date up to Day 28 or ET
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.
Measured: Baseline, Week 4 or ET
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.
Measured: Baseline, Week 4 or ET
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.
Measured: Baseline, Weeks 1, 2, 3 and 4 or ET
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.
Measured: Baseline, Day 0 through Day 28 or ET
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.
Measured: Baseline, Day 0 through Day 28 or ET
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.
Measured: Baseline, Week 4 or ET
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).
Measured: Weeks 2 and 4 or ET
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.
Measured: Baseline, Day 14, Day 28 or ET
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.
Measured: Baseline, Day 28 or ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startDec 2006
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381095
- Sponsor's protocol ID
- A0081128
- Acronym
- COPE
- Status last verified
- Apr 2019
- First submitted
- 25 Sep 2006
- Last updated
- 20 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25135035
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-Controlled Trial Of The Efficacy And Tolerability Of Flexibly Dosed Pregabalin In The Treatment Of Cancer-Induced Bone Pain
- ClinicalTrials.gov ID
- NCT00381095
- Acronym / sponsor ID
- COPE / A0081128
- Conditions
- Bone Neoplasms, Pain, Intractable, Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 27 Sep 2006 (estimated)
- Results
- Posted 27 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pregabalinflexible dosing |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinCapsule, Flexible-dosing, Double-blind. Treatment duration is 28 days at 100-600 mg/day administered BID+ taper (6 days). | Drug | 1 |
| PlaceboPlacebo | Drug | 2 |
Primary outcome
Duration Adjusted Average Change (DAAC) From Baseline in Daily Worst Pain, Fixed Dosing Date to Day 28
Time frame: Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET)
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.
12 secondary outcomes
DAAC From Baseline in Daily Worst Pain, Days 1 Through 28
Time frame: Baseline, Days 1 through 28 or ET
DAAC From Baseline in Daily Worst Pain, Day 1 to End of Dose Adjustment
Time frame: Baseline, Day 1 to End of Dose Adjustment or ET
DAAC From Baseline in Daily Worst Pain 14 Days After Fixed Dosing Date Up to Day 28
Time frame: Baseline, 14 Days After Fixed Dosing Date up to Day 28 or ET
Change From Baseline in Modified Brief Pain Inventory (mBPI-sf) Pain Severity Index Score at Week 4
Time frame: Baseline, Week 4 or ET
Change From Baseline in mBPI-sf Interference Index Score at Week 4
Time frame: Baseline, Week 4 or ET
Change From Baseline in Average Pain Scores at Weeks 1, 2, 3 and 4
Time frame: Baseline, Weeks 1, 2, 3 and 4 or ET
Change From Baseline in Total Daily Dose of Opioids Day 0 Through Day 28
Time frame: Baseline, Day 0 through Day 28 or ET
Change From Pre-Baseline in Total Daily Dose of Morphine Equivalents Day 0 Through Day 28
Time frame: Baseline, Day 0 through Day 28 or ET
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 4
Time frame: Baseline, Week 4 or ET
Patient Global Impression of Change (PGIC)
Time frame: Weeks 2 and 4 or ET
Change From Baseline in Opioid-Related Symptoms Distress Scale (OR-SDS) at Day 14 and Day 28
Time frame: Baseline, Day 14, Day 28 or ET
Change From Baseline in Eastern Cooperative Oncology Group Performance (ECOG) Status Scale at Day 28
Time frame: Baseline, Day 28 or ET
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25135035Sjolund 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
55 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin in people with Bone Neoplasms and Pain, Intractable, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 55 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Czechia, Poland, Hungary, Russia and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration Adjusted Average Change (DAAC) From Baseline in Daily Worst Pain, Fixed Dosing Date to Day 28 (time frame: Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00381095, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.