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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973973

  Hide Study Locations
Locations
United States, Arizona
Site Reference ID/Investigator# 57960
Phoenix, Arizona, United States, 85015
Site Reference ID/Investigator# 57967
Phoenix, Arizona, United States, 85032
Site Reference ID/Investigator# 57948
Tucson, Arizona, United States, 85710
United States, California
Site Reference ID/Investigator# 57943
Encinitas, California, United States, 92024
Site Reference ID/Investigator# 57944
San Diego, California, United States, 92108
Site Reference ID/Investigator# 57963
San Diego, California, United States, 92123
Site Reference ID/Investigator# 57977
Vallejo, California, United States, 94589
United States, Colorado
Site Reference ID/Investigator# 57970
Colorado Springs, Colorado, United States, 80907
Site Reference ID/Investigator# 57956
Denver, Colorado, United States, 80220
United States, Florida
Site Reference ID/Investigator# 57953
Boynton Beach, Florida, United States, 33472
Site Reference ID/Investigator# 57968
Clearwater, Florida, United States, 33759
Site Reference ID/Investigator# 57973
New Port Richey, Florida, United States, 34652
United States, Illinois
Site Reference ID/Investigator# 57962
Chicago, Illinois, United States, 60612
Site Reference ID/Investigator# 57957
Oak Brook, Illinois, United States, 60523
United States, Indiana
Site Reference ID/Investigator# 57954
South Bend, Indiana, United States, 46601
United States, Kansas
Site Reference ID/Investigator# 57966
Wichita, Kansas, United States, 67208
United States, Kentucky
Site Reference ID/Investigator# 57958
Louisville, Kentucky, United States, 40291
United States, Maryland
Site Reference ID/Investigator# 57976
Baltimore, Maryland, United States, 21229
United States, North Carolina
Site Reference ID/Investigator# 57947
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
Site Reference ID/Investigator# 57974
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Site Reference ID/Investigator# 57964
Medford, Oregon, United States, 97504
United States, South Carolina
Site Reference ID/Investigator# 57946
Columbia, South Carolina, United States, 29201
Site Reference ID/Investigator# 57959
Greenville, South Carolina, United States, 29615
United States, Tennessee
Site Reference ID/Investigator# 57971
Chattanooga, Tennessee, United States, 37404
Site Reference ID/Investigator# 57955
Nashville, Tennessee, United States, 37203
United States, Texas
Site Reference ID/Investigator# 57969
Dallas, Texas, United States, 75390-8852
Site Reference ID/Investigator# 57949
Houston, Texas, United States, 77030
Site Reference ID/Investigator# 57942
San Antonio, Texas, United States, 78229
Site Reference ID/Investigator# 57972
San Antonio, Texas, United States, 78229
Site Reference ID/Investigator# 57951
Schertz, Texas, United States, 78154
United States, Utah
Site Reference ID/Investigator# 57961
Pleasant Grove, Utah, United States, 84062
Site Reference ID/Investigator# 57965
Sandy, Utah, United States, 84070
United States, Virginia
Site Reference ID/Investigator# 57950
Richmond, Virginia, United States, 23225
Site Reference ID/Investigator# 57978
Richmond, Virginia, United States, 23233
Site Reference ID/Investigator# 57975
Virginia Beach, Virginia, United States, 23451
United States, Washington
Site Reference ID/Investigator# 57945
Seattle, Washington, United States, 98105
United States, Wisconsin
Site Reference ID/Investigator# 57952
LaCrosse, Wisconsin, United States, 54601
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 April 17, 2014