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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00381095
Other study ID # A0081128
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date December 2006
Est. completion date October 2010

Study information

Verified date April 2019
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 152
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Pfizer Investigational Site Hamilton Ontario
Czechia Pfizer Investigational Site Benesov U Prahy
Czechia Pfizer Investigational Site Horovice
Czechia Pfizer Investigational Site Jablonec nad Nisou
Czechia Pfizer Investigational Site Plzen
Czechia Pfizer Investigational Site Praha 1 - Nove Mesto
Czechia Pfizer Investigational Site Praha 6 - Hradcany
Egypt Pfizer Investigational Site Cairo
Finland Pfizer Investigational Site Helsinki
Finland Pfizer Investigational Site Joensuu
France Pfizer Investigational Site Bordeaux Cedex
France Pfizer Investigational Site Villejuif
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Nyiregyhaza
Hungary Pfizer Investigational Site Szentes
Hungary Pfizer Investigational Site Tata
Italy Pfizer Investigational Site Aviano (PN)
Italy Pfizer Investigational Site Milano
Korea, Republic of Pfizer Investigational Site Daegu
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Mexico Pfizer Investigational Site México D.F
Mexico Pfizer Investigational Site Monterrey Nuevo Leon
Peru Pfizer Investigational Site Lima
Peru Pfizer Investigational Site Lima
Philippines Pfizer Investigational Site Manila
Philippines Pfizer Investigational Site Quezon City
Poland Pfizer Investigational Site Bialystok
Poland Pfizer Investigational Site Gdansk
Poland Pfizer Investigational Site Kielce
Poland Pfizer Investigational Site Lodz
Poland Pfizer Investigational Site Warszawa
Poland Pfizer Investigational Site Warszawa
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Saint-Petersburg
Russian Federation Pfizer Investigational Site Vsevolozhsk Vsevolozhsk District, Leningrad Region
Spain Pfizer Investigational Site Alcorcon Madrid
Spain Pfizer Investigational Site Lleida
Sweden Pfizer Investigational Site Orebro
Sweden Pfizer Investigational Site Stockholm
Taiwan Pfizer Investigational Site Kaohsiung Hsien
Taiwan Pfizer Investigational Site Taichung City
Taiwan Pfizer Investigational Site Taipei
Thailand Pfizer Investigational Site Rachathewi Bangkok
Thailand Pfizer Investigational Site Ratchathewi Bangkok
United States Pfizer Investigational Site Canton Ohio
United States Pfizer Investigational Site Celebration Florida
United States Pfizer Investigational Site Dover Ohio
United States Pfizer Investigational Site Edina Minnesota
United States Pfizer Investigational Site Kissimmee Florida
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Pensacola Florida
United States Pfizer Investigational Site Pensacola Florida
Venezuela Pfizer Investigational Site Caracas Distrito Capital

Sponsors (1)

Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Venezuela,  Canada,  Czechia,  Egypt,  Finland,  France,  Hungary,  Italy,  Korea, Republic of,  Mexico,  Peru,  Philippines,  Poland,  Russian Federation,  Spain,  Sweden,  Taiwan,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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). 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. 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. Baseline, Day 28 or ET
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