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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by AdeTherapeutics Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Saskatchewan
Information provided by (Responsible Party):
AdeTherapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01701193
First received: October 3, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

The purpose of this study is to determine whether an amino acid is an effective treatment to prevent abdominal/pelvic scar tissue.


Condition Intervention Phase
Pelvic Adhesions
Drug: Amino Acid
Drug: Saline
Phase 1

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: Prevention
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

Resource links provided by NLM:


Further study details as provided by AdeTherapeutics Inc.:

Primary Outcome Measures:
  • Adhesion Reduction [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events in patients from dose administration to 8-week follow up [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 38
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline
1g/kg of body weight, 1 time intra-abdominal administration at time of surgery
Drug: Saline
Placebo Comparator
Experimental: Amino Acid
1g/kg of body weight, 1 time intra-abdominal administration at time of surgery
Drug: Amino Acid
Dipeptide

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701193

Contacts
Contact: Dominique C Singh, RN (306) 292-7756 dominique.singh@usask.ca

Locations
Canada, Saskatchewan
Saskatoon Health Region Recruiting
Saskatoon, Saskatchewan, Canada
Contact: Dominique C Singh, RN    (306) 292-7756    dominique.singh@usask.ca   
Principal Investigator: Donna Chizen, MD, FRCSC         
Sponsors and Collaborators
AdeTherapeutics Inc.
University of Saskatchewan
Investigators
Principal Investigator: Donna Chizen, MD, FRCSC University of Saskatchewan
  More Information

No publications provided

Responsible Party: AdeTherapeutics Inc.
ClinicalTrials.gov Identifier: NCT01701193     History of Changes
Other Study ID Numbers: ADE001-2011
Study First Received: October 3, 2012
Last Updated: October 3, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Pregnancy, Ectopic
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Pregnancy Complications

ClinicalTrials.gov processed this record on October 22, 2014