A Proof of Concept Study of L-Alanyl-L-Glutamine for the Reduction of Peritoneal Adhesions
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|ClinicalTrials.gov Identifier: NCT04250467|
Recruitment Status : Completed
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Temple Therapeutics BV
Information provided by (Responsible Party):
Temple Therapeutics BV
This study evaluates whether L-Alanyl-L-Glutamine can reduce the incidence, extent and severity of adhesions after myomectomy. Half of the participants will receive L-Alanyl-L-Glutamine and the other half of participants will receive a saline placebo at the time of myomectomy.
|Condition or disease||Intervention/treatment||Phase|
|Adhesion; Peritoneum||Drug: L-Alanyl/L-Glutamine Drug: Physiologic saline||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Proof of Concept Study of L-Alanyl-L-Glutamine for the Reduction of Peritoneal Adhesions in Adult Females Undergoing Myomectomy|
|Actual Study Start Date :||February 15, 2015|
|Actual Primary Completion Date :||October 20, 2016|
|Actual Study Completion Date :||October 20, 2016|
Participants receiving intraperitoneal administration of L-Alanyl-L-Glutamine at the time of myomectomy.
Sterile solution of L-Alanyl-L-Glutamine, 400mg/mL in water for injection. It is dosed at 1g/kg of body weight and is instilled into the peritoneum at the time of surgery. The active ingredient, glutamine, is a conditionally essential amino acid component of nutritional supplements.
Other Name: Evitar
Placebo Comparator: Placebo-Physiological Saline
Participants receiving intraperitoneal administration of physiological saline at the time of myomectomy.
Drug: Physiologic saline
Other Name: Placebo
Primary Outcome Measures :
- Efficacy of L-Alanyl-L-Glutamine [ Time Frame: 6-8 weeks ]A statistically significant reduction in the incidence, extent and severity of adhesions observed in the L-Alanyl-L-Glutamine treated group compared to the saline control group using the American Fertility Society grading system.
Secondary Outcome Measures :
- Number of participants with treatment-related adverse events as assessed by clinical blood work abnormalities and physical examination. [ Time Frame: 8 weeks ]Adverse events, adverse drug reactions and clinical laboratory abnormalities will be analyzed be using the chi-square test or Fisher's Exact test. Any continuous measurement in physical examination and clinical laboratory will be analyzed by t-test or Wilcoxon rank test.
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