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

Viatris

Status and phase: Terminated; Phase 4

Conditions: Pain, Intractable; Cancer; Bone Neoplasms

Treatments: Drug: Pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00381095

A0081128

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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152 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

flexible dosing

Treatment:

Drug: Pregabalin

2

Placebo Comparator group

Treatment:

Drug: Placebo