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

Phase 4

Terminated

• Conditions: Bone Neoplasms; Cancer; Pain, Intractable
• Interventions: Drug: Placebo; Drug: Pregabalin

• Registration Number: NCT00381095
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Study Timeline

• Study First Submitted: 2006-09-25
• Study First Submitted QC: 2006-09-25
• Study First Posted: 2006-09-27
• Study Start: 2006-12
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2011-08-18
• Results First Submitted QC: 2011-08-18
• Results First Posted: 2011-09-27
• Status Verified: 2019-04
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 152

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Pregabalin	flexible dosing

Primary Outcome Measures

Name	Time	Method
Duration Adjusted Average Change (DAAC) From Baseline in Daily Worst Pain, Fixed Dosing Date to Day 28	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

Name	Time	Method
DAAC From Baseline in Daily Worst Pain, Day 1 to End of Dose Adjustment	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.
DAAC From Baseline in Daily Worst Pain, Days 1 Through 28	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.
Change From Baseline in Modified Brief Pain Inventory (mBPI-sf) Pain Severity Index Score at Week 4	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.
Change From Baseline in Total Daily Dose of Opioids Day 0 Through Day 28	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.
Patient Global Impression of Change (PGIC)	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).
Change From Pre-Baseline in Total Daily Dose of Morphine Equivalents Day 0 Through Day 28	Baseline, Day 0 through Day 28 or ET	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	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.
DAAC From Baseline in Daily Worst Pain 14 Days After Fixed Dosing Date Up to Day 28	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.
Change From Baseline in Opioid-Related Symptoms Distress Scale (OR-SDS) at Day 14 and Day 28	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.
Change From Baseline in mBPI-sf Interference Index Score at Week 4	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.
Change From Baseline in Average Pain Scores at Weeks 1, 2, 3 and 4	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.
Change From Baseline in Eastern Cooperative Oncology Group Performance (ECOG) Status Scale at Day 28	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇻🇪 Caracas, Distrito Capital, Venezuela