A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis

Endometriosis Clinical Trial

Official title:

A Phase II, Multicenter, Long-term Extension Study to Compare the Safety and Efficacy of TAK-385 (10, 20, and 40 mg) Following Oral Administration for 12 Weeks or More in the Treatment of Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452685
• Other study ID #: TAK-385/OCT-101
• Secondary ID: U1111-1123-6973J
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2011
• Last updated: May 7, 2014
• Start date: March 2012
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the long term safety and efficacy of TAK-385, once daily (QD) following continued administration in participants who completed a Phase II dose-finding study.

Description:

This study is a long-term extension study for evaluation of the safety and efficacy of TAK-385 following administration for 24 weeks (calculated from Visit 3 in the TAK-385/CCT-101 study) in participants from the Phase II dose-finding study (TAK-385/CCT-101 study).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Participants who have completed TAK-385/CCT-101 study

Exclusion Criteria:

1. Participants who had an adverse event in TAK-385/CCT-101 study which makes continued administration of the study drug difficult

2. Participants who became unable to comply with the protocol due to onset of a new disease, symptom, finding, or aggravation of clinical laboratory findings

3. Participants in whom investigator deems that the study drug shows no efficacy based on the level of pain, menstruation status, and the status of analgesic drug intake in TAK-385/CCT-101 study, or that study continuation represents an unacceptable risk

4. Participants in whom investigator deems that study continuation is difficult due to the occurrence of low estrogen symptoms in TAK-385/CCT-101 study which were attributed to the pharmacological effects of the study drug taking into account the level and frequency of the adverse events etc. as well as the risk-benefit of participants.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Placebo
TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
• TAK-385
TAK-385 10 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
• TAK-385
TAK-385 20 mg, tablets orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
• TAK-385
TAK-385 40 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
• Leuprorelin acetate
TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density	Measured by Dual-energy X-ray absorptiometry (DXA)	Up to Week 24.	Yes
Primary	Treatment-emergent Adverse Events	Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit (Week 16)	Up to Week 16	Yes
Primary	Vital Signs	Vital signs will include body temperature, sitting blood pressure and pulse (bpm).	Up to Week 24	Yes
Primary	Body Weight		Up to Week 24	Yes
Primary	Electrocardiograms		Up to Week 24.	Yes
Primary	Laboratory Values		Up to Week 24	Yes
Primary	Serum NTx	NTx is one of the biochemical bone metabolism markers	Up to Week 24	Yes
Primary	Serum BAP	BAP is one of the biochemical bone metabolism markers	Up to Week 24	Yes
Secondary	Visual Analogue Scale (VAS) Score for Pelvic Pain	Pelvic pain will be assessed using the VAS as pain evaluation scale	Up to Week 24	No
Secondary	VAS Score for Dyspareunia	Dyspareunia will be assessed using the VAS as pain evaluation scale	Up to Week 24	No