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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
History of Changes
  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:

U.S. FDA Resources

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
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 May 21, 2013