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

September 7, 2009
January 2, 2013
August 2009
September 2010   (final data collection date for primary outcome measure)
  • 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 ]
Dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia assessments [ Time Frame: Daily assessments over 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00973973 on ClinicalTrials.gov Archive Site
  • 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 ]
Safety endpoints: Physical examinations, vital signs, clinical laboratory tests, ECG, vaginal bleeding, and adverse events [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy and Safety Study of NBI-56418 Sodium in Subjects With Endometriosis
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-56418 Sodium in Subjects With Endometriosis

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Endometriosis
  • Pain
  • Drug: NBI-56418
    150 mg immediate release (IR) taken daily, 24 week duration
  • Drug: Placebo
    Matching placebo tablet taken daily, 8 week duration
  • Experimental: NBI-56418 150 mg q.d.
    Intervention: Drug: NBI-56418
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
137
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00973973
NBI-56418-0901
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Laura Williams, MD AbbVie
AbbVie
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP