Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis

December 24, 2013 updated by: Otsuka Pharmaceutical Co., Ltd.
The purpose of this study is to examine the efficacy and safety of OPC-249 by once daily inhalation at 0 (placebo), 30, 60 or 120 IU for 4 weeks in patients with pain due to osteoporosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu Region, Japan
      • Hokkaido Region, Japan
      • Kanto Region, Japan
      • Kinki Region, Japan
      • Kyushu Region, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients who fulfill all of the following items

    • Patients with primary osteoporosis
    • Patients who have existing 1-4 vertebral fractures
    • Patients with back pain persisting for one week or more
    • Postmenopausal women between 46 and less than 80 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: OPC-249
1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
Placebo Comparator: 1
Drug: OPC-249
1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
Active Comparator: 3
Drug: OPC-249
1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
Active Comparator: 4
Drug: OPC-249
1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain (Subjective Symptom)
Time Frame: Baseline and Week 4

Change of pain measured by 100 mm visual analogue scale (VAS) at week4 from baseline.

Regarding VAS (dotted onto a 100 mm line), 0 mm means "No Pain" and 100 mm means "Worst Pain Imaginable".
Baseline and Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement Rate of Pain (Doctor's Judgment)
Time Frame: Baseline and Week 4

Percentage of participants qualified for improvement of pain by doctor's judgement.

Qualification: stopped or almost stopped, alleviated, slightly alleviated, unchanged, worsend.

Improvement defind by "stopped or almost stopped" or "alleviated".
Baseline and Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

July 16, 2007

First Submitted That Met QC Criteria

July 19, 2007

First Posted (Estimate)

July 20, 2007

Study Record Updates

Last Update Posted (Estimate)

January 30, 2014

Last Update Submitted That Met QC Criteria

December 24, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 249-06-002OD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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