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

Primary Purpose

Pain Due to Osteoporosis

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
OPC-249
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Due to Osteoporosis

Eligibility Criteria

46 Years - 79 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Pain (Subjective Symptom)
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".

Secondary Outcome Measures

Improvement Rate of Pain (Doctor's Judgment)
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".

Full Information

First Posted
July 16, 2007
Last Updated
December 24, 2013
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00504426
Brief Title
Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis
Official Title
Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Due to Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Arm Title
4
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
OPC-249
Intervention Description
1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
Primary Outcome Measure Information:
Title
Pain (Subjective Symptom)
Description
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".
Time Frame
Baseline and Week 4
Secondary Outcome Measure Information:
Title
Improvement Rate of Pain (Doctor's Judgment)
Description
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".
Time Frame
Baseline and Week 4

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
46 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsuhisa Saito
Organizational Affiliation
Division of New Product Evaluation and Development
Official's Role
Study Director
Facility Information:
City
Chubu Region
Country
Japan
City
Hokkaido Region
Country
Japan
City
Kanto Region
Country
Japan
City
Kinki Region
Country
Japan
City
Kyushu Region
Country
Japan

12. IPD Sharing Statement

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

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