Efficacy and Safety Study of NBI-56418 Sodium in Subjects With Endometriosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00973973
First received: September 7, 2009
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to evaluate NBI-56418 compared to placebo (also known as a sugar pill) for its effects on endometriosis related pelvic pain and its safety.


Condition Intervention Phase
Endometriosis
Pain
Drug: NBI-56418
Drug: Placebo
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: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-56418 Sodium in Subjects With Endometriosis

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Dysmenorrhea assessments [ Time Frame: Daily assessments over 8 weeks ] [ Designated as safety issue: No ]
  • nonmenstrual pelvic pain assessments [ Time Frame: Daily assessments over 8 weeks ] [ Designated as safety issue: No ]
  • dyspareunia assessments [ Time Frame: Daily assessments over 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety endpoint: Physical examination [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]
  • Safety endpoint: Vital signs [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]
  • Safety endpoint: Clinical laboratory tests [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]
  • Safety endpoint: electrocardiogram (ECG) [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]
  • Safety endpoint: Vaginal bleeding [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]
  • Safety endpoint: Adverse Events [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 137
Study Start Date: August 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NBI-56418 150 mg q.d. Drug: NBI-56418
150 mg immediate release (IR) taken daily, 24 week duration
Placebo Comparator: Placebo Drug: Placebo
Matching placebo tablet taken daily, 8 week duration

Detailed Description:

This is a Phase 2, multicenter, randomized, double-blind, placebo controlled parallel group study to assess the efficacy and safety of 150 mg NBI-56418 administered once daily (q.d.) for up to 24 weeks. Approximately 120 subjects will be randomized (1:1) to 150 mg NBI-56418 q.d. or placebo q.d. for the first 8 weeks of dosing. Following 8 weeks of dosing, subjects will continue in the study for an additional 16 weeks in an open-label phase where all subjects still enrolled in the study will receive 150 mg q.d.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Be female, aged 18 to 49 years, inclusive.
  • Have moderate to severe pelvic pain due to endometriosis.
  • Have a history of regular menstrual cycles.
  • Have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within 8 years of the start of screening.
  • Have a Body Mass Index (BMI) of 18 to 36 kg/m2, inclusive.
  • Agree to use two forms of non-hormonal contraception during the study.

Exclusion Criteria

  • Are currently receiving GnRH agonist, a GnRH antagonist other than NBI-56418, or danazol or have received any of these agents within 6 months of the start of screening.
  • Are currently receiving DMPA-SC or DMPA-IM or have received any of these agents within 3 months of the start of screening.
  • Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month.
  • Have had surgery for endometriosis within the last month.
  • Have had a hysterectomy or bilateral oophorectomy.
  • Are using systemic steroids on a chronic or regular basis within 3 months.
  • Have uterine fibroids ≥3 cm in diameter.
  • Have pelvic pain that is not caused by endometriosis.
  • Have unstable medical condition or chronic disease.
  • Have been pregnant within the last six months.
  • Currently breast feeding.
  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: NCT00973973

  Show 37 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Laura Williams, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00973973     History of Changes
Other Study ID Numbers: NBI-56418-0901
Study First Received: September 7, 2009
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Pelvic Pain
NBI-56418
Endometriosis

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 21, 2014