Efficacy and Safety Study of NBI-56418 Sodium in Subjects With Endometriosis
This study has been completed.
Sponsor:
AbbVie (prior sponsor, Abbott)
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
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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
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Hide Study LocationsLocations
| 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 May 23, 2013