DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets

Information source: Takeda
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Involutional Osteoporosis

Intervention: NE-58095 (Drug); NE-58095 (Drug); NE-58095NF (Drug); NE-58095NF (Drug); NE-58095NF (Drug); NE-58095NF (Drug); NE-58095NF (Drug)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: Takeda

Official(s) and/or principal investigator(s):
Senior Manager, Study Director, Affiliation: Takeda

Summary

The present phase II/III, multicenter, randomized, double-blind, parallel group comparative study is designed to evaluate the efficacy and safety of oral administration of NE-58095NF(New formulation) tablets for 12 months in patients with involutional osteoporosis. For this study, patients receiving oral NE-58095 2. 5-mg tablets once daily for 12 months are set as the control group.

Clinical Details

Official title: A Phase II/III Multicenter, Randomized, Double-blind, Parallel Group Comparative Study to Evaluate the Efficacy and Safety of Oral Administration of NE-58095NF Tablets Versus Once-daily Oral Administration of NE-58095 2.5-mg Tablets for the Treatment of Involutional Osteoporosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Mean bone mineral density of the lumbar spine (L2- L4) determined by dual energy X-ray absorptiometry (DXA)

Frequency of Adverse events

Vtal signs (As vital signs, body temperature (axilla), blood pressure while sitting (rest for 5 minutes or longer), and pulse (bpm) will be measured)

Laboratory parameters (bloodbiochemistry, hematology, and urinalysis)

Secondary outcome:

Percent changes from baseline in mean bone mineral density of the L2-L4 lumbar spine (determined by DXA) at the end of the treatment period

Percent changes from baseline in mean bone mineral density of the femur (whole bone, trochanteric region, and neck region) (determined by DXA) at the end of the treatment period

Percent changes from baseline in biochemical bone metabolic markers at each evaluation time point

Incidence of non-traumatic new vertebral body fractures

Detailed description: The primary objective of the present study is to verify the non-inferiority of oral administration of NE-58095NF tablets for 12 months to once-daily oral administration of NE-58095 2. 5-mg tablets for 12 months, in terms of efficacy in patients with involutional osteoporosis. Secondary objectives of the present study are as follows: to compare the safety of oral administration of NE-58095NF tablets for 12 months with the safety of once-daily oral administration of NE-58095 tablets (at 2. 5 mg) for 12 months in patients with involutional osteoporosisat time of wakening.

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients with a diagnosis of involutional osteoporosis 2. Male or female outpatients (including patients admitted to the hospital for tests) aged ≥ 50 years at the time of consent 3. Women for whom at least 2 years has passed since the last natural menstruation Exclusion Criteria: 1. Patients with secondary osteoporosis 2. Patients with diseases (other than secondary osteoporosis) that present with decreased bone mass 3. Patients with findings that affects the measurement of mean bone mineral density of the lumbar spine by dual-energy X-ray absorptiometry (DXA) 4. Patients with a history of radiotherapy to the lumbar spine or the pelvis 5. Patients who are planning to receive surgical dental procedures such as tooth extraction (including dental implant treatment) during the treatment period 6. Patients with a history of treatment with any anti-RANKL monoclonal antibodies or parathyroid hormone products within 1 year before the start of the treatment period 7. Patients with a history of treatment with any bisphosphonate products within 24 weeks before the start of the treatment period 8. Patients who have received any NFugs that affect bone metabolism within 8 weeks before the start of the treatment period 9. Patients with disorders such as esophagitis, peptic ulcer (e. g., esophageal ulcer, gastric ulcer, and duodenal ulcer), or gastrointestinal bleeding 10. Patients with disorders that delay esophageal emptying (e. g., dysphagia, esophagostenosis, or achalasia of the esophagus) 11. Patients with hypocalcemia 12. Patients with hypercalcemia 13. Patients with a diagnosis of renal calculus 14. Patients with serious renal, hepatic, or cardiac disease 15. Patients who have received surgical dental procedures, such as a tooth extraction (including dental implant treatment), but whose dental problems remain unresolved at the start of the treatment period.

Locations and Contacts

Nagoya-shi, Aichi, Japan

Chiba-shi, Chiba, Japan

Narashino-shi, Chiba, Japan

Fukuoka-shi, Fukuoka, Japan

Kitakyushu-shi, Fukuoka, Japan

Onga-gun, Fukuoka, Japan

Ebetsu-shi, Hokkaido, Japan

Sapporo-shi, Hokkaido, Japan

Kako-gun, Hyogo, Japan

Morioka-shi, Iwate, Japan

Atsugi-shi, Kanagawa, Japan

Kawasaki-shi, Kanagawa, Japan

Yokohama-shi, Kanagawa, Japan

Zushi-shi, Kanagawa, Japan

Kumamoto-shi, Kumamoto, Japan

Tamana-shi, Kumamoto, Japan

Sendai-shi, Miyagi, Japan

Tagajo-shi, Miyagi, Japan

Miyazaki-shi, Miyazaki, Japan

Saito-shi, Miyazaki, Japan

Higashi Osaka-shi, Osaka, Japan

Saitama-shi, Saitama, Japan

Daito-ku, Tokyo, Japan

Setagaya-ku, Tokyo, Japan

Wakayama-shi, Wakayama, Japan

Additional Information

Starting date: February 2014
Last updated: August 11, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017