CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
L-Alanyl/L-Glutamine +1 moredrug
Likely dose
L-Alanyl/L-Glutamine 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01701193
NCT01701193Phase 2Completed

A Randomized Double-Blind Controlled Proof-of-Concept Study of Alanyl-Glutamine for Reduction of Post-Myomectomy Adhesions

Temple Therapeutics BV·interventional·Posted Oct 5, 2012·Updated May 7, 2021

In Brief

A Phase 2 clinical trial evaluating L-Alanyl/L-Glutamine and Physiologic saline for Pelvic Adhesions. Completed, enrolled 47 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUkraine
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 5, 2012
Enrollment StartFeb 15, 2015
Primary CompletionOct 20, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.7 years ago

Interventions

L-Alanyl/L-Glutaminedrug

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.

Physiologic salinedrug

Placebo