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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
  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

  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# 57972
San Antonio, Texas, United States, 78229
Site Reference ID/Investigator# 57942
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 November 20, 2014