Health TrialsbyHealthPanel

Preventing Gastrointestinal Disturbance in Patients After Longitudinal Laparotomy.

ConditionIleus Postoperative
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorOrexa BV

About this trial

This is a multi-center, randomized, double blind, placebo-controlled, phase 2 pilot efficacy study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient must be able to understand the requirements of the study and give written informed consent prior to study start.

Female patients aged between 18 and 75 years (both inclusive).

Gynecologic surgery performed completely by longitudinal laparotomy.

Patient with ECOG Performance status up to 1.

Disqualifiers

Patient has a history of gastrectomy, total colectomy, stoma creation, short bowel syndrome.

Patient has pre-operative ileus.

Patient is taking opioid analgesics longer than two post-operative days, exceeding a dosing of 35 mg morphine equivalent per day.

Chemotherapy treatment within 10 days after longitudinal surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ORE001

    Drug

    Administration before major meal

  • Placebo

    Drug

    Administration before major meal

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: ORE001Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

I-FEED Post Operative Day 3

To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD3. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

Time frame
Post Operative Day 3

Secondary outcomes

1

I-FEED Post Operative Day 1

To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD1. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

Time frame
Post Operative Day 1
2

I-FEED Post Operative Day 2

To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD2. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

Time frame
Post Operative Day 2
3

I-FEED Post Operative Day 4

To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD4. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

Time frame
Post Operative Day 4
4

I-FEED Post Operative Day 5

To evaluate the efficacy of oral ORE-001 compared to placebo in reducing the gastrointestinal disturbance/intolerance and the occurrence of postoperative ileus (POI) in patients after longitudinal laparotomy defined by scoring of the postoperative I-FEED scores at POD5. The I-FEED score ranges from 0 to 14. The higher the score the more severe are the symptoms.

Time frame
Post Operative Day 5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Orexa BV

Lead sponsor

QPS Holdings LLC

Collaborator

Source ClinicalTrials.gov
Apply now