A study of the safety and tolerability of GSK221149A in preterm labour

• Research type

  Research Study

• Full title

  Study OTA113142: A randomized, double-blind, placebo-controlled, dose ranging study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK221149A administered intravenously in healthy, pregnant females, with uncomplicated preterm labor between 30(0/7) - 35(6/7) weeks gestation

• IRAS ID

  23193

• Eudract number

  2009-011782-92

• ISRCTN Number

  N/A

• Research summary

  This is a randomised, double-blind, placebo-controlled study to investigate the safety, efficacy, pharmacokinetics and pharmacodynamics of GSK221149A administered intravenously in healthy, pregnant females with uncomplicated pre-term labour between 30(0/7) - 35(6/7) week gestation. Patients will be randomised to receive either active GSK221149A IV or placebo IV. Each patient will receive a loading dose of 6mg over 5 mins, followed by a constant intravenous infusion of 6mg/h for 8 hours. The dose may be increased to 12mg/h after the first hour of treatment if the patient does not exhibit a satisfactory response. If after dose increase the patient still does not exhibit a satisfactory response, they should be withdrawn from study medication and a rescue tocolytic administered at the discretion of the investigator.Eligible patients will be between the ages of 18-45 years of age with symptoms of pre-term labour, ie contractions at a frequency of 4 per 30 mins or 6 per hour, cervical dilatation of > 2 cm.Approximately 64 patients will be enrolled in about 8 countries throughout the world. However outside of the UK, the study will be run as an amendment to protocol OTA105256.Predose measurements will include safety bloods, assessment of uterine contractions and dilation, urine dipstick and ECG.During the infusion, blood samples will be taken for pharmacokinetic analysis. Maternal blood pressure, heart rate and ECGs will be measured at specified timepoints. Uterine contractions, fetal heart rate and adverse events will be continuously assessed.Patients will be discharged 6 hours after the end of the IV infusion or at the discretion of the investigator if parturition has not occurred. Infants will be assessed post-natally at the planned full-term (40weeks) timepoint 1 week for growth and development.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  09/H1211/65

• Date of REC Opinion

  3 Jun 2009

• REC opinion

  Favourable Opinion