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

Phase 4TerminatedNCT00381095

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.152 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

152

Conditions

Bone Neoplasms Pain, Intractable Cancer

Interventions

PregabalinDRUG

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

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (55)

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET)

Secondary Outcomes

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.

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

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.

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Celebration, Florida, United States

Pfizer Investigational Site

Kissimmee, Florida, United States

Pfizer Investigational Site

Pensacola, Florida, United States

Pfizer Investigational Site

Pensacola, Florida, United States

Pfizer Investigational Site

Louisville, Kentucky, United States

Pfizer Investigational Site

Edina, Minnesota, United States

Pfizer Investigational Site

Canton, Ohio, United States

Pfizer Investigational Site

Dover, Ohio, United States

Pfizer Investigational Site

Hamilton, Ontario, Canada

Pfizer Investigational Site

Benesov U Prahy, Czechia

...and 45 more locations

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

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

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.

Time frame: 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.

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

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

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.

Time frame: 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.

Time frame: 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).

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

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

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.

Time frame: Baseline, Day 28 or ET