Two Phase Extension Trial of SP668 to Investigate the Safety and Tolerability of Sustained Release Fesoterodine in Subjects With Overactive Bladder: a Double-Blind Phase Followed by an Open-Label Extension Phase

NCT00220389

Last updated date
Study Location
Schwarz
RTP, North Carolina, , United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Overactive bladder

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Overactive BladderLong Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder. NCT00658684
  1. Inegeku, Chibashi, Chiba-ken
  2. Amagasaki-shi, Hyogo
  3. Kaibara-cho, tanba-shi, Hyogo
  4. Akashi-shi, Hyougo
  5. Chuou-ku, koube-shi, Hyougo
  6. Nishinomiya-shi, Hyougo
  7. Kawasakishi, Kanagawaken
  8. Sagamihara-shi, Kanagawa
  9. Nara-shi, Nara
  10. Osaka-shi, Osaka
  11. Edogawa-ku, Tokyo
  12. Shibuya-ku, Tokyo
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Overactive BladderEvaluation of the Link Between Bladder Sensation and Changes in Skin Electrical Conductance and Heart Rate. NCT00481728
  1. Zurich,
Female
18 Years+
years
MULTIPLE SITES
Overactive BladderA Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients NCT00425100
  1. Homewood, Alabama
  2. Huntsville, Alabama
  3. La Mesa, California
  4. Orangevale, California
  5. Aurora, Colorado
  6. West Palm Beach, Florida
  7. Aurora, Illinois
  8. Pratt, Kansas
  9. Shreveport, Louisiana
  10. Milford, Massachusetts
  11. Omaha, Nebraska
  12. Westampton, New Jersey
  13. Kingston, New York
  14. New York, New York
  15. Poughkeepsie, New York
  16. Winston-Salem, North Carolina
  17. Cincinnati, Ohio
  18. Bethany, Oklahoma
  19. Eugene, Oregon
  20. Sellersville, Pennsylvania
  21. Houston, Texas
  22. Salt Lake City, Utah
  23. Salt Lake City, Utah
  24. Milwaukee, Wisconsin
  25. Bruxelles,
  26. Edegem,
  27. Gent,
  28. Jette,
  29. Turnhout,
  30. Alajuela Centro, Alajuela
  31. San Jose,
  32. Brno-Bohunice,
  33. Hradec Kralove,
  34. Praha 2,
  35. Praha 5,
  36. Alzey,
  37. Berlin,
  38. Duisburg,
  39. Frankfurt,
  40. Marburg,
  41. Muelheim A.d. Ruhr,
  42. Muenchen,
  43. Bucheon-si, Gyunggi-do
  44. Busan,
  45. Daejeon,
  46. Jeonnam,
  47. Seoul,
  48. Seoul,
  49. Lodz,
  50. Myslowice,
  51. Bratislava,
  52. Malacky,
  53. Piestany,
  54. Presov,
  55. Skalica,
  56. Chernivtsi,
  57. Dnipropetrovsk,
  58. Kharkiv,
  59. Odessa,
  60. Zaporizhzhia,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Two Phase Extension Trial of SP668 to Investigate the Safety and Tolerability of Sustained Release Fesoterodine in Subjects With Overactive Bladder: a Double-Blind Phase Followed by an Open-Label Extension Phase
Official Title  ICMJE Two Phase Extension Trial of SP668 to Investigate the Safety and Tolerability of Sustained Release Fesoterodine in Subjects With Overactive Bladder(OAB): a Double-Blind Phase Followed by an Open-Label Extension Phase
Brief Summary

This extension trial of SP668 consists of two phases: double-blind treatment and open-label extension. The trial provides subjects the option of long-term treatment with sustained release (SR) fesoterodine (SPM 907) and to assess long-term subject safety, tolerability and efficacy.

Double-Blind: Subjects remained on either fesoterodine 4mg, 8mg or 12mg depending on their dose assignment in SP668. Previous SP668 placebo subjects received fesoterodine 4mg.

Open-Label: Subjects received fesoterodine 8mg with a one time option to reduce the dose to 4mg and a one time option to increase again to 8mg.

The primary variables focus on long-term safety and tolerability and include the observation and assessment of adverse events, residual urinary volumes, laboratory parameters, changes in ECG, physical and urological examinations and subject's assessment of treatment tolerance.

Secondary efficacy variables include various parameters derived from micturition diaries, count of subjects and their dose choice throughout the trial and subject's assessment of treatment efficacy.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Overactive Bladder
Intervention  ICMJE Drug: SPM 907
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Overactive bladder
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00220389
Other Study ID Numbers  ICMJE SP669
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Brooke DerbyUCB Pharma
PRS Account Pfizer
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP