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A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain;; Bone Neoplasms;; Neoplasm Metastasis

Intervention: ibandronate [Bondronat] (Drug); zoledronic acid (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 followed by Bondronat 5Omg po daily from day 22 to week 24) or zoledronic acid (4mg iv on day 1, and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

Clinical Details

Official title: A Randomized, Double-Blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Pain, as measured by Brief Pain Inventory and analgesic use

Secondary outcome:

Performance score and QoL measures

AEs and laboratory parameters

Opioid side effects

Skeletal-related events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- patients with malignant bone disease;

- patients with moderate to severe pain.

Exclusion Criteria:

- patients who have received a bisphosphonate within 3 weeks from the signing of

informed consent;

- patients receiving concurrent investigational therapy, or who have received

investigational therapy within 30 days of the first scheduled day of dosing;

- untreated esophagitis or gastric ulcers;

- recent or pre-scheduled radiotherapy to bone;

- patients who are pregnant or breast-feeding.

Locations and Contacts

Bahia Blanca B8001HXM, Argentina

Buenos Aires 1426, Argentina

Buenos Aires C1426BOR, Argentina

Rosario 2000, Argentina

Santa Fe 03000, Argentina

Adelaide 5011, Australia

Brisbane 4101, Australia

Santiago, Chile

Vina Del Mar, Chile

Hamburg 22143, Germany

Kalyftaki Kifissia, Greece

Thessaloniki 57010, Greece

Guatemala City, Guatemala

Budapest 1122, Hungary

Budapest 1529, Hungary

Deszk 6772, Hungary

Szeged 6720, Hungary

Rozzano 20089, Italy

Torino 10126, Italy

La Paz 23040, Mexico

Mexicali 21100, Mexico

Mexico City 14050, Mexico

Monterrey 64320, Mexico

Panama City 83-0669, Panama

Poznan 61-878, Poland

Poznan 60-569, Poland

San Juan 00935, Puerto Rico

Kazan 420029, Russian Federation

Moscow 115478, Russian Federation

Moscow 117837, Russian Federation

Moscow 125284, Russian Federation

Moscow, Russian Federation

Obninsk 249020, Russian Federation

St Petersburg 197022, Russian Federation

St Petersburg 197758, Russian Federation

St Gallen 9007, Switzerland

Manchester M20 4BX, United Kingdom

Sutton SM2 5PT, United Kingdom

Miami, Florida 33136, United States

Macon, Georgia 31201, United States

Houston, Texas 77030, United States

Additional Information

Starting date: August 2005
Last updated: May 20, 2008

Page last updated: August 23, 2015

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