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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00504426
Recruitment Status : Completed
First Posted : July 20, 2007
Results First Posted : January 30, 2014
Last Update Posted : January 30, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Pain Due to Osteoporosis Drug: OPC-249 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis
Study Start Date : July 2007
Primary Completion Date : July 2008
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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".



Secondary Outcome Measures :
  1. 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".



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   46 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504426


Locations
Japan
Chubu Region, Japan
Hokkaido Region, Japan
Kanto Region, Japan
Kinki Region, Japan
Kyushu Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Katsuhisa Saito Division of New Product Evaluation and Development
More Information

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00504426     History of Changes
Other Study ID Numbers: 249-06-002OD
First Posted: July 20, 2007    Key Record Dates
Results First Posted: January 30, 2014
Last Update Posted: January 30, 2014
Last Verified: December 2013

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases