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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00381095
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : September 27, 2006
Results First Posted : September 27, 2011
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Bone Neoplasms Pain, Intractable Cancer Drug: Pregabalin Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2006
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: 1
flexible dosing
Drug: Pregabalin
Capsule, Flexible-dosing, Double-blind. Treatment duration is 28 days at 100-600 mg/day administered BID+ taper (6 days).

Placebo Comparator: 2 Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. DAAC From Baseline in Daily Worst Pain, Days 1 Through 28 [ Time Frame: Baseline, Days 1 through 28 or ET ]
    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.

  2. 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 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.

  3. 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 ]
    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.

  4. Change From Baseline in Modified Brief Pain Inventory (mBPI-sf) Pain Severity Index Score at Week 4 [ Time Frame: Baseline, Week 4 or ET ]
    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.

  5. Change From Baseline in mBPI-sf Interference Index Score at Week 4 [ Time Frame: Baseline, Week 4 or ET ]
    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.

  6. 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 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.

  7. 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 baseline in total daily dose of opioids immediate release (IR), sustained release (SR) formulations separately and combined.

  8. 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 ]
    IR and SR formulations separately and combined. Change was day x minus baseline.

  9. Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 4 [ Time Frame: Baseline, Week 4 or ET ]
    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.

  10. Patient Global Impression of Change (PGIC) [ Time Frame: Weeks 2 and 4 or ET ]
    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).

  11. 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 ]
    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.

  12. Change From Baseline in Eastern Cooperative Oncology Group Performance (ECOG) Status Scale at Day 28 [ Time Frame: Baseline, Day 28 or ET ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381095


Locations
Show Show 55 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00381095    
Other Study ID Numbers: A0081128
First Posted: September 27, 2006    Key Record Dates
Results First Posted: September 27, 2011
Last Update Posted: April 23, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Bone Neoplasms
Pain, Intractable
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs