taPentadol cLinical prAcTice IN belgiUM

NCT03814993 | Completed

• 1 other identifier: PLATINUM
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 11

Brief Summary

Multicenter observational study to determine the long-term tolerability and analgesic effectiveness of oral tapentadol in patients suffering from severe pain syndromes, refractory to other strong opioids.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability 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;
• Males and females, 18 years and older;
• Patients suffering from severe pain;
• Pain symptoms refractory to strong opioids (in previous treatment);
• Due to side effects
• Due to insufficient analgesic effectiveness
• Due to opioid induced hyperalgesia.

You may not qualify if:

• Severe renal and/or hepatic insufficiency;
• Known and/or strong suspicion of allergy to tapentadol;
• Previous treatment with tapentadol;
• Presence of any condition for which tapentadol is contraindicated as per its approved labelling information in Belgium;
• The patient has no access to a mobile phone and web browser. During the study, an online system is used to receive messages (SMS and e-mail) for the completing of the online assessments (through web browser).

Sponsors & Collaborators

• Dafne Balemans: lead
• Grünenthal GmbH: collaborator

Study Sites (11)

AZ Monic

Antwerp, 2100, Belgium

Location

University Hospital Antwerp

Antwerp, 2650, Belgium

Location

Huisartspraktijk Van Peer

Boechout, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Jessa Ziekenhuis Hasselt

Hasselt, Belgium

Location

AZ Groeninge

Kortrijk, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHU Liège (Sart Tilman)

Liège, 4000, Belgium

Location

Huisartspraktijk De Vaart

Mechelen, Belgium

Location

Grand Hôpital Charleroi

Montignies-sur-Sambre, 6061, Belgium

Location

AZ Turnhout

Turnhout, 2300, Belgium

Location

MeSH Terms

Conditions

Somatoform Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Guy Hans, Prof.

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

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
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-02

Locations

BE (11)