Skip to main content
OpenTrials
Completed

NCT Number: NCT00504426

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Due to Osteoporosis

Age range

46 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Chubu Region, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPC-249

Drug

1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)

Primary outcomes

  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 outcomes

  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".

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Jul 20, 2007
Registry last updated
Jan 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.