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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00504426
First received: July 16, 2007
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Pain Due to Osteoporosis
Drug: OPC-249
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Pain (Subjective Symptom) [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]

    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) [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]

    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".



Enrollment: 101
Study Start Date: July 2007
Study Completion Date: May 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   46 Years to 79 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00504426     History of Changes
Other Study ID Numbers: 249-06-002OD
Study First Received: July 16, 2007
Results First Received: July 1, 2013
Last Updated: December 24, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on August 26, 2014