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Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate

NCT00577720 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2012-01-13

Study results available
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Summary

To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.

Conditions

  • Postmenopausal Women

Interventions

DRUG

risedronate

35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks

DRUG

risedronate

35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks

DRUG

risedronate

50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks

DRUG

risedronate

50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks

Sponsors & Collaborators

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Lu A Sun, MD, PhD · Procter and Gamble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-01-31
Completion
2007-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00577720 on ClinicalTrials.gov