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Efficacy and Safety in a Randomised Acute Pain Study of MR308: STARDOM2.

NCT03062644 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1138

Last updated 2018-09-20

No results posted yet for this study

Summary

The MR308-3502 study is a multicenter double-blind, randomised, placebo- and active comparator-controlled study in female subjects to evaluate the efficacy and safety of MR308 with acute pain after TAH or STAH (total or subtotal abdominal hysterectomy).

Conditions

  • Acute Pain

Interventions

DRUG

MR308

two times daily; Mode of Administration:oral

DRUG

MR308

four times daily; Mode of Administration:oral

DRUG

MR308

two times daily; Mode of Administration:oral

DRUG

MR308

given four times daily to maintain the blind; Mode of Administration:oral

Sponsors & Collaborators

  • Mundipharma Research GmbH & Co KG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-05
Primary Completion
2018-06-29
Completion
2018-06-29

Countries

  • Belarus
  • Bulgaria
  • Canada
  • Hungary
  • Latvia
  • Poland
  • Russia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03062644 on ClinicalTrials.gov