Trials Sponsors Conditions Drugs Pricing

Conditions

Severe Pain Syndromes

Outcome Measures

Primary Outcomes (1)

Difference in occurrence of gastrointestinal side effects (nausea, vomiting and constipation) between baseline and week 15
Differences in occurence of the PRO-CTCAE items: Nausea, vomiting and constipation
baseline - week 15

Secondary Outcomes (10)

Difference in frequency, severity and interference of selected side effects (dizziness, fatigue, itching, headache, dry mouth, nausea, vomiting, constipation) from baseline to week 52
baseline - week 52
Change From Baseline in Pain Scores on the Numeric Rating Scale baseline to different time points during long-term follow-up
baseline - week 52
Change of health-related quality of life from baseline to different time points during long-term follow-up
baseline - week 52
Change of health-related quality of life from baseline to different time points during long-term follow-up
baseline - week 52
Change of functional status of the patient from baseline to different time points during long-term follow-up
baseline - week 52
+5 more secondary outcomes

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

All patients suffering from severe pain that did not respond to previous treatment with strong opioids (either due to (1) insufficient analgesic effectiveness, (2) intolerable side effects from previous opioid treatment or (3) opioid induced hyperalgesia)

You may qualify if:

Subjects should be capable of giving their informed consent;

Sponsors & Collaborators

Dafne Balemans
Otherlead
Grünenthal GmbH
Industrycollaborator

Study Sites (11)

AZ Monic

Antwerp, 2100, Belgium

University Hospital Antwerp

Antwerp, 2650, Belgium

Huisartspraktijk Van Peer

Boechout, Belgium

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Jessa Ziekenhuis Hasselt

Hasselt, Belgium

AZ Groeninge

Kortrijk, Belgium

UZ Leuven

Leuven, 3000, Belgium

MeSH Terms

Conditions

Somatoform Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

Guy Hans, Prof.
University Hospital, Antwerp
PRINCIPAL INVESTIGATOR

Enrollment

55 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Clinical Trial Center UZA

Study Record Dates

First Submitted

January 15, 2019

First Posted

January 24, 2019

Study Start

July 29, 2019

Actual (reported)

taPentadol cLinical prAcTice IN belgiUM

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations