Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

August 15, 2019 updated by: Bausch Health Americas, Inc.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA Regimen

This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative colitis (UC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligible participants will be randomized to 1 of the following 2 treatment arms:

  1. Budesonide MMX 9 mg (1 tablet)
  2. Placebo (tablet indistinguishable from budesonide MMX 9 mg tablet)

The assigned study drug will be taken as a single oral tablet each morning after breakfast. In addition to the study drug, all participants will continue their existing background oral 5-ASA regimen during the treatment period.

Study Type

Interventional

Enrollment (Actual)

510

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria
        • Santarus Clinical Investigational Site 4003
      • Plovdiv, Bulgaria
        • Santarus Clinical Investigational Site 4004
      • Plovdiv, Bulgaria
        • Santarus Clinical Investigational Site 4009
      • Ruse, Bulgaria
        • Santarus Clinical Investigational Site 4008
      • Sofia, Bulgaria
        • Santarus Clinical Investigational Site 4001
      • Sofia, Bulgaria
        • Santarus Clinical Investigational Site 4002
      • Sofia, Bulgaria
        • Santarus Clinical Investigational Site 4005
      • Sofia, Bulgaria
        • Santarus Clinical Investigational Site 4007
      • Sofia, Bulgaria
        • Santarus Clinical Investigational Site 4010
      • Sofia, Bulgaria
        • Santarus Clinical Investigational Site 4011
  • Canada
      • Calgary, Canada
        • Santarus Clinical Investigational Site 2007
      • London, Canada
        • Santarus Clinical Investigational Site 2005
      • Quebec, Canada
        • Santarus Clinical Investigational Site 2006
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A1R9
        • Santarus Clinical Investigational Site 2003
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Santarus Clinical Investigational Site 2008
    • Ontario
      • London, Ontario, Canada
        • Santarus Clinical Investigational Site 2004
      • Ottawa, Ontario, Canada
        • Santarus Clinical Investigational Site 2010
      • Vaughan, Ontario, Canada, L4L4Y7
        • Santarus Clinical Investigational Site 2002
    • Quebec
      • Montreal, Quebec, Canada
        • Santarus Clinical Investigational Site 2009
      • Sherbrooke, Quebec, Canada, J1G2E8
        • Santarus Clinical Investigational Site 2001
  • Czechia
      • Hradec Kralove, Czechia
        • Santarus Clinical Investigational Site 3001
      • Hradec Kralove, Czechia
        • Santarus Clinical Investigational Site 3006
      • Labem, Czechia
        • Santarus Clinical Investigational Site 3005
      • Olomouc, Czechia
        • Santarus Clinical Investigational Site 3003
      • Prague, Czechia
        • Santarus Clinical Investigational Site 3009
      • Praha, Czechia
        • Santarus Clinical Investigational Site 3004
      • Praha, Czechia
        • Santarus Clinical Investigational Site 3007
      • Tabor, Czechia
        • Santarus Clinical Investigational Site 3002
      • Usti nad Orlici, Czechia
        • Santarus Clinical Investigational Site 3010
      • Valasske Mezirici, Czechia
        • Santarus Clinical Investigational Site 3011
  • Estonia
      • Tallinn, Estonia
        • Santarus Clinical Investigational Site 8001
  • Hungary
      • Bekescsaba, Hungary
        • Santarus Clinical Investigational Site 5010
      • Budapest, Hungary
        • Santarus Clinical Investigational Site 5008
      • Budapest, Hungary
        • Santarus Clinical Investigational Site 5009
      • Debrecen, Hungary
        • Santarus Clinical Investigational Site 5001
      • Gyula, Hungary
        • Santarus Clinical Investigational Site 5003
      • Kaposvar, Hungary
        • Santarus Clinical Investigational Site 5004
      • Miskolc, Hungary
        • Santarus Clinical Investigational Site 5002
      • Mosonmagyarovar, Hungary
        • Santarus Clinical Investigational Site 5006
      • Pecs, Hungary
        • Santarus Clinical Investigational Site 5011
      • Szeged, Hungary
        • Santarus Clinical Investigational Site 5005
      • Vac, Hungary
        • Santarus Clinical Investigational Site 5007
  • Latvia
      • Riga, Latvia
        • Santarus Clinical Investigational Site 8101
      • Riga, Latvia
        • Santarus Clinical Investigational Site 8102
      • Riga, Latvia
        • Santarus Clinical Investigational Site 8103
  • Lithuania
      • Kaunas, Lithuania
        • Santarus Clinical Investigational Site 8202
      • Vilnius, Lithuania
        • Santarus Clinical Investigational Site 8201
      • Vilnius, Lithuania
        • Santarus Clinical Investigational Site 8203
  • Poland
      • Elblag, Poland
        • Santarus Clinical Investigational Site 6003
      • Krakow, Poland
        • Santarus Clinical Investigational Site 6001
      • Sopot, Poland
        • Santarus Clinical Investigational Site 6002
      • Szczecin, Poland
        • Santarus Clinical Investigational Site 6006
      • Warszawa, Poland
        • Santarus Clinical Investigational Site 6004
      • Warszawa, Poland
        • Santarus Clinical Investigational Site 6008
      • Warszawy, Poland
        • Santarus Clinical Investigational Site 6005
  • Russian Federation
      • Lipetsk, Russian Federation
        • Santarus Clinical Investigational Site 9016
      • Moscow, Russian Federation
        • Santarus Clinical Investigational Site 9005
      • Moscow, Russian Federation
        • Santarus Clinical Investigational Site 9010
      • Nizhny Novgorod, Russian Federation
        • Santarus Clinical Investigational Site 9004
      • Ryazan, Russian Federation
        • Santarus Clinical Investigational Site 9003
      • Saint Petersburg, Russian Federation
        • Santarus Clinical Investigational Site 9008
      • Saint Petersburg, Russian Federation
        • Santarus Clinical Investigational Site 9013
      • Saint Petersburg, Russian Federation
        • Santarus Clinical Investigational Site 9014
      • Saratov, Russian Federation
        • Santarus Clinical Investigational Site 9009
      • St Petersburg, Russian Federation
        • Santarus Clinical Investigational Site 9001
      • Stavropol, Russian Federation
        • Santarus Clinical Investigational Site 9007
      • Ufa, Russian Federation
        • Santarus Clinical Investigational Site 9006
      • Volgograd, Russian Federation
        • Santarus Clinical Investigational Site 9017
  • Ukraine
      • Crimea, Ukraine
        • Santarus Clinical Investigational Site 7010
      • Donetsk, Ukraine
        • Santarus Clinical Investigational Site 7002
      • Kharkiv, Ukraine
        • Santarus Clinical Investigational Site 7001
      • Kharkiv, Ukraine
        • Santarus Clinical Investigational Site 7004
      • Kyiv, Ukraine
        • Santarus Clinical Investigational Site 7006
      • Kyiv, Ukraine
        • Santarus Clinical Investigational Site 7008
      • Vinnytsia, Ukraine
        • Santarus Clinical Investigational Site 7005
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Santarus Clinical Investigational Site 1043
      • Lakewood, California, United States, 90712
        • Santarus Clinical Investigational Site 1071
      • San Diego, California, United States, 92114
        • Santarus Clinical Investigational Site 1003
    • Colorado
      • Littleton, Colorado, United States, 80120
        • Santarus Clinical Investigational Site 1063
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Santarus Clinical Investigational Site 1028
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Santarus Clinical Investigational Site 1035
      • Jacksonville, Florida, United States, 32256
        • Santarus Clinical Investigational Site 1045
      • Largo, Florida, United States, 33777
        • Santarus Clinical Investigational Site 1001
      • Maitland, Florida, United States, 32751
        • Santarus Clinical Investigational Site 1024
      • Port Orange, Florida, United States, 32127
        • Santarus Clinical Investigational Site 1029
      • Winter Park, Florida, United States, 32789
        • Santarus Clinical Investigational Site 1010
      • Zephyrhills, Florida, United States, 33613
        • Santarus Clinical Investigational Site 1002
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Santarus Clinical Investigational Site 1050
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Santarus Clinical Investigational Site 1075
      • Oak Lawn, Illinois, United States, 60453
        • Santarus Clinical Investigational Site 1065
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Santarus Clinical Investigational Site 1058
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Santarus Clinical Investigational Site 1032
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Santarus Clinical Investigational Site 1044
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Santarus Clinical Investigational Site 1016
      • Novi, Michigan, United States, 48377
        • Santarus Clinical Investigational Site 1081
      • Wyoming, Michigan, United States, 49159
        • Santarus Clinical Investigational Site 1015
      • Ypsilanti, Michigan, United States, 48197
        • Santarus Clinical Investigational Site 1068
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Santarus Clinical Investigational Site 1074
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Santarus Clinical Investigational Site 1061
    • New York
      • Cheektowaga, New York, United States, 14225
        • Santarus Clinical Investigational Site 1021
      • Great Neck, New York, United States, 11023
        • Santarus Clinical Investigational Site 1072
      • New York, New York, United States, 10028
        • Santarus Clinical Investigational Site 1031
    • North Carolina
      • Wilmington, North Carolina, United States, 28403
        • Santarus Clinical Investigational Site 1073
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Santarus Clinical Investigational Site 1080
      • Cleveland, Ohio, United States, 44195
        • Santarus Clinical Investigational Site 1078
      • Dayton, Ohio, United States, 45415
        • Santarus Clinical Investigational Site 1082
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Santarus Clinical Investigational Site 1064
      • Sayre, Pennsylvania, United States, 18840
        • Santarus Clinical Investigational Site 1006
    • Texas
      • Austin, Texas, United States, 78705
        • Santarus Clinical Investigational Site 1059
      • Houston, Texas, United States, 77030
        • Santarus Clinical Investigational Site 1039
      • Pasadena, Texas, United States, 77505
        • Santarus Clinical Investigational Site 1005
    • Utah
      • Lancaster, Utah, United States, 84341
        • Santarus Clinical Investigational Site 1014
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Santarus Clinical Investigational Site 1038
      • Christiansburg, Virginia, United States, 24073
        • Santarus Clinical Investigational Site 1025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 to 75 years, inclusive.
  2. Established diagnosis of UC, based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings.
  3. Active mild or moderate UC with an ulcerative colitis disease activity index (UCDAI) score ≥4 and ≤10, with a mucosal appearance score of ≥1, and physician's rating of disease activity of 1 or 2.
  4. Experiencing active UC (flare) despite a therapeutic dose of an oral 5-ASA (for example, mesalamine ≥2.4 g/day for ≥6 weeks prior to randomization, or equivalent). At screening, photographic evidence of active UC based on mucosal appearance must be obtained.
  5. Women of childbearing potential or men of reproductive potential must be willing to use an acceptable form of contraception.
  6. Able to comprehend the full nature and purpose of the study, including possible risks and side effects, and also able to comply with all requirements of the study. Must be able to understand and voluntarily sign an informed consent prior to any study procedures.

Exclusion Criteria:

  1. Limited distal proctitis (from anal verge to 15 centimeters [cm] above the pectineal line).
  2. Severe UC (UCDAI >10 or physician global assessment [PGA] >2), or non-active UC (UCDAI <4).
  3. Infectious colitis or any recent history of infectious colitis (within 30 days of Screening).
  4. Active malignancy or carcinoma in situ within the last 5 years (treated non-melanoma skin cancers are not exclusionary).
  5. Active ulcer or bleeding disorder that may affect evaluation of blood in the stool.
  6. Evidence or history of toxic megacolon or bowel resection.
  7. Crohn's disease or indeterminate colitis.
  8. Known hypersensitivity to budesonide or any ingredients of the budesonide MMX tablets.
  9. Active tuberculosis or other active systemic or local bacterial, fungal, or viral infection.
  10. Liver cirrhosis, evident hepatic or renal disease or insufficiency, or significant impairment of the biohumoral parameters (≥2.5*upper limit of normal [ULN] for alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, or ≥2*ULN for creatinine). Elevations in bilirubin due to benign conditions such as Gilbert's syndrome are not exclusionary.
  11. Severe diseases in other organs or systems.
  12. Local or systemic complications or other pathological states requiring therapy with corticosteroids and/or immunosuppressive agents.
  13. Type 1 diabetes.
  14. Glaucoma or with a family history of glaucoma in first-degree relatives.
  15. Known hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), according to the local privacy policy.
  16. Severe anemia (<9 g/deciliter [dL] hemoglobin), leukopenia (<2.5*10^9 white blood cells [WBC]/liter [L]), or granulocytopenia (<1.2*10^9 cells/L).
  17. Participants with a history of pancolitis (disease that extends to the hepatic flexure or beyond) for ≥8 years or left-sided colitis (disease confined to the left colon [that is, distal to the splenic flexure]) ≥15 years who have not yet completed a surveillance colonoscopy for dysplasia/colorectal cancer screening within the past year.
  18. Prior budesonide MMX treatment.
  19. Use of oral corticosteroids including other budesonide formulations within the last 4 weeks prior to randomization.
  20. Use of any rectal 5-ASA or corticosteroid formulations within the last 2 weeks prior to randomization.
  21. Use of immunosuppressive agents within the last 8 weeks prior to randomization.
  22. Use of anti-tumor necrosis factor-alpha (TNFα) agents or other biologic therapies within the last 3 months prior to randomization.
  23. Participation in experimental therapeutic studies within 30 days of randomization (or within the last 3 months if in an anti-TNFα or biologic agent study). Note: participants who participated in observational-only studies (and who did not receive study therapy) are not excluded.
  24. Any other medical condition that, in the Principal Investigator's opinion, would make the administration of the study drug or study procedures hazardous to the participant or obscure the interpretation of adverse events (AEs) by the appropriate independent ethics committee/institutional review board.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Budesonide MMX
Participants will receive 1 oral tablet of budesonide MMX 9 mg for 56 days. Additionally, participants will continue to receive the same dose of their existing oral 5-ASA medication from their treating physician.
Drug: Budesonide MMX®
Oral tablet taken daily in the morning after breakfast.
Other Names:
  • Budesonide Multi-Matrix System
Drug: 5-ASA

Acceptable oral 5-ASA medications to be received during the study include:

  • Asacol®, Asacol® HD, Lialda®, Pentasa® (generic: mesalamine), minimum daily dose ≥2.4 grams (g)
  • Azulfidine® (generic: sulfasalazine), minimum daily dose ≥4.0 g
  • Dipentum® (generic: olsalazine), minimum daily dose ≥2.0 g
  • Colazal®, Colazide® (generic: balsalazide), minimum daily dose ≥6.75 g
Placebo Comparator: Placebo
Participants will receive 1 oral tablet of matching budesonide MMX placebo for 56 days. Additionally, participants will continue to receive the same dose of their existing oral 5-ASA medication from their treating physician.
Drug: 5-ASA

Acceptable oral 5-ASA medications to be received during the study include:

  • Asacol®, Asacol® HD, Lialda®, Pentasa® (generic: mesalamine), minimum daily dose ≥2.4 grams (g)
  • Azulfidine® (generic: sulfasalazine), minimum daily dose ≥4.0 g
  • Dipentum® (generic: olsalazine), minimum daily dose ≥2.0 g
  • Colazal®, Colazide® (generic: balsalazide), minimum daily dose ≥6.75 g
Drug: Placebo
Matching budesonide MMX placebo oral tablet taken daily in the morning after breakfast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Achieved Clinical Remission at Day 56
Time Frame: Baseline up to Day 56
Clinical remission defined as a score of 0 for rectal bleeding and 0 for stool frequency components from the Ulcerative Colitis Disease Activity Index (UCDAI). UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Stool frequency and rectal bleeding were based on information recorded in daily participant diaries. The diary entries were averaged for rectal bleeding and stool frequency for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest to) Day 56. The 5 days did not include any days of the flexible sigmoidoscopy (or colonoscopy) or the preparation for the flexible sigmoidoscopy (or colonoscopy). These averages were rounded to integer values. If either subscore could not be calculated because of missing data, the score for that UCDAI component was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis. Participants who had clinical remission at Baseline were classified as non-responders.
Baseline up to Day 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants of Who Achieved Clinical Response at Day 56
Time Frame: Baseline up to Day 56
Clinical response defined as an improvement in UCDAI from Baseline of ≥3 points with a rectal bleeding score ≤1. UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Rectal bleeding was based on information recorded in daily participant diaries. The diary entries were averaged for rectal bleeding for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest to) Day 56. The 5 days did not include any days of the flexible sigmoidoscopy (or colonoscopy) or the preparation for the flexible sigmoidoscopy (or colonoscopy). These averages were rounded to integer values. If either subscore could not be calculated because of missing data, the score for that UCDAI component was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis.
Baseline up to Day 56
Number of Participants Who Achieved UCDAI Remission at Day 56
Time Frame: Baseline up to Day 56
UCDAI remission was defined as a total UCDAI score ≤1 with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance of the colon. UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Stool frequency and rectal bleeding were based on information recorded in daily participant diaries and mucosal appearance was based on endoscopy results. The diary entries were averaged for rectal bleeding and stool frequency for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest to) Day 56. The 5 days did not include any days of the flexible sigmoidoscopy (or colonoscopy) or the preparation for the flexible sigmoidoscopy (or colonoscopy). These averages were rounded to integer values. If the subscore could not be calculated because of missing data, the score for that UCDAI component was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis.
Baseline up to Day 56
Number of Participants Who Achieved Endoscopic Remission at Day 56
Time Frame: Screening and Day 56
Endoscopic remission was defined as a score of 0 in the mucosal appearance component subscore of the UCDAI at Day 56. UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Mucosal appearance was based on endoscopy results. If the mucosal appearance subscore could not be calculated because of missing data, endoscopic remission was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis.
Screening and Day 56
Number of Participants Who Achieved Histologic Healing at Day 56
Time Frame: Baseline and Day 56
Participants achieved histologic healing if histologic assessments of all biopsy specimens were graded as 0 (normal mucosa). If the score for ≥1 sample was missing, the overall score at that visit was set to missing. Participants with insufficient data at Day 56 were excluded from analysis.
Baseline and Day 56
Number of Participants With Treatment Failure at Day 56
Time Frame: Baseline up to Day 56
Treatment failure was defined as an unchanged, worsened, or missing UCDAI score at Day 56. UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Stool frequency and rectal bleeding was based on information recorded in daily participant diaries and mucosal appearance was based on endoscopy results. The diary entries were averaged for rectal bleeding and stool frequency for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest to) Day 56. The 5 days did not include any days of the flexible sigmoidoscopy (or colonoscopy) or the preparation for the flexible sigmoidoscopy (or colonoscopy). These averages were rounded to integer values. If the subscore could not be calculated because of missing data, the score for that UCDAI component was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis.
Baseline up to Day 56
Change From Baseline in Inflammatory Bowel Disease-Quality of Life (IBD-QoL) Questionnaire Scores
Time Frame: Baseline, Days 14, 28, and 56
The IBD-QoL questionnaire was self-completed by the participant. The IBD-QoL is a disease-specific instrument to evaluate the quality of life of participants with UC. This 32-item questionnaire has 4 dimensions: bowel function, emotional function, systemic symptoms, and social function. The total score is presented, which ranges from 32 to 224, with higher scores indicating a better quality of life. The scores of participants in remission usually range from 170 to 190. If >50% of the questionnaire answers for a particular dimension were missing, this dimension score was set to missing. The total score for the IBD-QoL was the sum of the domain scores, however, if any dimension score was missing, the total IBD-QoL score was set to missing.
Baseline, Days 14, 28, and 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2012

Primary Completion (Actual)

October 2, 2013

Study Completion (Actual)

October 2, 2013

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

February 13, 2012

First Posted (Estimate)

February 14, 2012

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

August 15, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C2011-0401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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