Not provided
Not provided
Not provided
Not provided
See termination reason in detailed description.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | flexible dosing |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Capsule, Flexible-dosing, Double-blind. Treatment duration is 28 days at 100-600 mg/day administered BID+ taper (6 days). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Days 1 through 28 or ET |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Celebration | Florida | 34747 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25135035 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
A0081128 terminated on 01-SEP-2010 due to slow enrollment, analysis at 50 percent (%) enrollment determined that increasing the sample size would require significant extension of enrollment period.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34 |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | Baseline, Day 28 or ET |
| Kissimmee |
| Florida |
| 34741 |
| United States |
| Pfizer Investigational Site | Pensacola | Florida | 32504 | United States |
| Pfizer Investigational Site | Pensacola | Florida | 32514 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40202 | United States |
| Pfizer Investigational Site | Edina | Minnesota | 55435 | United States |
| Pfizer Investigational Site | Canton | Ohio | 44718 | United States |
| Pfizer Investigational Site | Dover | Ohio | 44622 | United States |
| Pfizer Investigational Site | Hamilton | Ontario | L8V 5C2 | Canada |
| Pfizer Investigational Site | Benesov U Prahy | 256 30 | Czechia |
| Pfizer Investigational Site | Hořovice | 268 31 | Czechia |
| Pfizer Investigational Site | Jablonec nad Nisou | 466 60 | Czechia |
| Pfizer Investigational Site | Pilsen | 301 00 | Czechia |
| Pfizer Investigational Site | Praha 1 - Nove Mesto | 110 00 | Czechia |
| Pfizer Investigational Site | Praha 6 - Hradcany | 160 00 | Czechia |
| Pfizer Investigational Site | Cairo | 11796 | Egypt |
| Pfizer Investigational Site | Helsinki | 00029 | Finland |
| Pfizer Investigational Site | Joensuu | 80210 | Finland |
| Pfizer Investigational Site | Bordeaux | 33076 | France |
| Pfizer Investigational Site | Villejuif | 94805 | France |
| Pfizer Investigational Site | Budapest | 1106 | Hungary |
| Pfizer Investigational Site | Budapest | 1125 | Hungary |
| Pfizer Investigational Site | Nyíregyháza | 4400 | Hungary |
| Pfizer Investigational Site | Szentes | 6600 | Hungary |
| Pfizer Investigational Site | Tata | 2890 | Hungary |
| Pfizer Investigational Site | Aviano (PN) | 33081 | Italy |
| Pfizer Investigational Site | Milan | 20133 | Italy |
| Pfizer Investigational Site | Monterrey | Nuevo León | 064460 | Mexico |
| Pfizer Investigational Site | México D.F | 14080 | Mexico |
| Pfizer Investigational Site | Lima | L-41 | Peru |
| Pfizer Investigational Site | Lima | L13 | Peru |
| Pfizer Investigational Site | Manila | 1015 | Philippines |
| Pfizer Investigational Site | Quezon City | 1102 | Philippines |
| Pfizer Investigational Site | Bialystok | 15-748 | Poland |
| Pfizer Investigational Site | Gdansk | 80-208 | Poland |
| Pfizer Investigational Site | Kielce | 25-734 | Poland |
| Pfizer Investigational Site | Lodz | 90-251 | Poland |
| Pfizer Investigational Site | Warsaw | 00-909 | Poland |
| Pfizer Investigational Site | Warsaw | 02-781 | Poland |
| Pfizer Investigational Site | Vsevolozhsk | Vsevolozhsk District, Leningrad Region | 188640 | Russia |
| Pfizer Investigational Site | Moscow | 125284 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 197089 | Russia |
| Pfizer Investigational Site | Daegu | 705-717 | South Korea |
| Pfizer Investigational Site | Seoul | 110-744 | South Korea |
| Pfizer Investigational Site | Seoul | 152-703 | South Korea |
| Pfizer Investigational Site | Alcorcón | Madrid | 28922 | Spain |
| Pfizer Investigational Site | Lleida | 25198 | Spain |
| Pfizer Investigational Site | Örebro | 701 85 | Sweden |
| Pfizer Investigational Site | Stockholm | 171 76 | Sweden |
| Pfizer Investigational Site | Kaohsiung Hsien | 833 | Taiwan |
| Pfizer Investigational Site | Taichung | 40705 | Taiwan |
| Pfizer Investigational Site | Taipei | 100 | Taiwan |
| Pfizer Investigational Site | Rachathewi | Bangkok | 10400 | Thailand |
| Pfizer Investigational Site | Ratchathewi | Bangkok | 10400 | Thailand |
| Pfizer Investigational Site | Caracas | Distrito Federal | 1010 | Venezuela |
Matching placebo capsules orally twice per day |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34 |
| BG001 | Placebo | Matching placebo capsules orally twice per day |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-To-Treat population (ITT): all randomized participants for whom at least one post-baseline efficacy evaluation was obtained; N= the number of participants with evaluable data analyzed; n= number of participants with evaluable data at the specific time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET) |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT; N= number of participants with evaluable data analyzed | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Days 1 through 28 or ET |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT; N= number of participants with evaluable data analyzed | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 1 to End of Dose Adjustment or ET |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT; N= number of participants with evaluable data analyzed | Posted | Mean | Standard Deviation | Units on a scale | Baseline, 14 Days After Fixed Dosing Date up to Day 28 or ET |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT; LOCF= Last observation carried forward; n= number of evaluable participants analyzed at each time point; N= number of participants with evaluable data analyzed | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 4 or ET |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT; LOCF; n= number of evaluable participants analyzed at each time point; N= number of participants with evaluable data analyzed | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 4 or ET |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Data not analyzed due to early study termination. | Posted | Baseline, Weeks 1, 2, 3 and 4 or ET |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Data no analyzed due to early study termination. | Posted | Baseline, Day 0 through Day 28 or ET |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Data not analyzed due to early study termination. | Posted | Baseline, Day 0 through Day 28 or ET |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT; LOCF; n= number of evaluable participants analyzed at each time point; N= number of participants with evaluable data analyzed; individual symptoms not analyzed | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 4 or ET |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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). | ITT; LOCF; n=number of evaluable participants analyzed at each time point; N= the number of participants with evaluable data analyzed | Posted | Mean | Standard Deviation | Units on a scale | Weeks 2 and 4 or ET |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Data not analyzed due to early study termination. | Posted | Baseline, Day 14, Day 28 or ET |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Data not analyzed due to early study termination. | Posted | Baseline, Day 28 or ET |
|
|
Not provided
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin | Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34 | 12 | 72 | 38 | 72 | ||
| EG001 | Placebo | Matching placebo capsules orally twice per day | 12 | 80 | 31 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Metabolic disorder | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Metastases to pleura | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
Efficacy parameters baseline=the last non-missing observation, up to the baseline visit for that efficacy parameter. Baseline mBPI scores=average score in week preceding randomization, minimum 4 datapoints. No formal hypothesis testing conducted.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| D010148 | Pain, Intractable |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| >=65 years |
|
| Male |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|