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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.

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

Condition or disease Intervention/treatment Phase
Pelvic Adhesions Drug: Amino Acid Drug: Saline Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Adhesion Reduction [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Adverse events in patients from dose administration to 8-week follow up [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701193


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

Locations
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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
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Principal Investigator: Donna Chizen, MD, FRCSC University of Saskatchewan
More Information
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Responsible Party: AdeTherapeutics Inc.
ClinicalTrials.gov Identifier: NCT01701193    
Other Study ID Numbers: ADE001-2011
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: October 5, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Pregnancy, Ectopic
Tissue Adhesions
Cicatrix
 Fibrosis
Pathologic Processes
Pregnancy Complications