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A Phase I Study For the Reduction of Scar Tissue in Adult Females Undergoing Surgery for an Ectopic Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01701193
Recruitment Status : Unknown
Verified October 2012 by AdeTherapeutics Inc..
Recruitment status was:  Recruiting
First Posted : October 5, 2012
Last Update Posted : October 5, 2012
Sponsor:
Collaborator:
University of Saskatchewan
Information provided by (Responsible Party):
AdeTherapeutics Inc.

Tracking Information
First Submitted Date  ICMJE October 3, 2012
First Posted Date  ICMJE October 5, 2012
Last Update Posted Date October 5, 2012
Study Start Date  ICMJE October 2012
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2012)
Adhesion Reduction [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2012)
Adverse events in patients from dose administration to 8-week follow up [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase I Study For the Reduction of Scar Tissue in Adult Females Undergoing Surgery for an Ectopic Pregnancy
Official Title  ICMJE A Randomized, Double-Blind, Placebo Controlled Phase I Study of an Amino Acid For the Reduction of Peritoneal Adhesions in Adult Females Undergoing a Laparoscopic Salpingostomy for the Removal of an Ectopic Pregnancy
Brief Summary The purpose of this study is to determine whether an amino acid is an effective treatment to prevent abdominal/pelvic scar tissue.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pelvic Adhesions
Intervention  ICMJE
  • Drug: Amino Acid
    Dipeptide
  • Drug: Saline
    Placebo Comparator
Study Arms  ICMJE
  • Placebo Comparator: Saline
    1g/kg of body weight, 1 time intra-abdominal administration at time of surgery
    Intervention: Drug: Saline
  • Experimental: Amino Acid
    1g/kg of body weight, 1 time intra-abdominal administration at time of surgery
    Intervention: Drug: Amino Acid
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 3, 2012)
38
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2013
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects are female
  • Subjects are 18 years of age or older at the time of consent
  • Subjects have a BMI between 17 and 35
  • Subjects or subject's legal representative must have signed informed consent form
  • Subjects have a preoperative diagnosis of an ectopic pregnancy with ultrasonographic confirmation of absence of an intrauterine ectopic pregnancy

Exclusion Criteria:

  • Subjects whose BMI is outside the range of 17 - 35
  • Subjects participating in another clinical trial with a drug or a device
  • Subjects who have participated in a clinical trial with a drug or device within 30 days prior to this study
  • Subjects with suspected or diagnosed co-existing intrauterine pregnancy
  • Subjects with suspected intraabdominal infection
  • Subjects who are immunocompromised
  • Subjects diagnosed with cancer
  • Subjects treated with hemostatic agents (e.g. fibrin sealant, collagen, oxidized cellulose)
  • Subjects treated with adhesion prevention agents other than the Anti-Adhesion Product (APP) (e.g. Intergel® Adhesion Prevention Solution, Seprafilm® Membrane)
  • Subjects taking anti-epileptic medications
  • Subjects who have been treated with Methotrexate or other chemotherapeutic agents
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01701193
Other Study ID Numbers  ICMJE ADE001-2011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AdeTherapeutics Inc.
Study Sponsor  ICMJE AdeTherapeutics Inc.
Collaborators  ICMJE University of Saskatchewan
Investigators  ICMJE
Principal Investigator: Donna Chizen, MD, FRCSC University of Saskatchewan
PRS Account AdeTherapeutics Inc.
Verification Date October 2012

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