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

• ClinicalTrials.gov Identifier: NCT01701193
• Recruitment Status: Unknown
• First Posted: October 5, 2012
• Last Update Posted: October 5, 2012
• Sponsor: AdeTherapeutics Inc.
• Collaborator: University of Saskatchewan
• Information provided by (Responsible Party): AdeTherapeutics Inc.

Tracking Information

• First Submitted Date: October 3, 2012
• First Posted Date: October 5, 2012
• Last Update Posted Date: October 5, 2012
• Study Start Date: October 2012
• Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 3, 2012): Adhesion Reduction [ Time Frame: 8 weeks ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: October 3, 2012): Adverse events in patients from dose administration to 8-week follow up [ Time Frame: 8 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase I Study For the Reduction of Scar Tissue in Adult Females Undergoing Surgery for an Ectopic Pregnancy
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Pelvic Adhesions

Intervention

• Drug: Amino Acid
  Dipeptide
• Drug: Saline
  Placebo Comparator

Study Arms

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 3, 2012): 38
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2013
• Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01701193
• Other Study ID Numbers: ADE001-2011
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: AdeTherapeutics Inc.
• Study Sponsor: AdeTherapeutics Inc.
• Collaborators: University of Saskatchewan

Investigators

• Principal Investigator: Donna Chizen, MD, FRCSC; University of Saskatchewan

• PRS Account: AdeTherapeutics Inc.
• Verification Date: October 2012