Oral Piroxicam Versus Buccal Fentanyl in Breakthrough Pain
The Analgesic Efficacy of Oral Piroxicam Versus Buccal Fentanyl in Cancer Breakthrough Pain in Patients With Bone Metastases
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
100 patients with Breakthrough pain will be allocated to receive either oral prioxicam (OP) (n=50) or sublingual fentanyl (SLF) (n=50) . Patients will be divided randomly into two equal groups: oral prioxicam (OP) Group and sublingual fentanyl citrate (SLF) Group, comprising of 50 patients each. Pain intensity level on a 0-10 visual analog scale (VAS), patients will be instructed about the use of a 10-cm visual analog scale (VAS) (0 = no pain to 10 = worst possible pain). frequency of Breakthrough pain throughout the day, onset of relief (0-5, 6-10, 11-15, or over 16 min), time required for dose titration, patient satisfaction and adverse effects were assessed at 3, 7, 15, and 30 days after starting the treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2014
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 3, 2015
CompletedFirst Posted
Study publicly available on registry
March 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 13, 2016
May 1, 2016
4 months
March 3, 2015
May 11, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
analgesic scale (assessmet of VAS immeditally after analgesic adminstration)
assessmet of VAS immeditally after analgesic adminstration
two hours
Study Arms (2)
oral perixicam
OTHER50 patients with Breakthrough pain will receive oral prioxicam for treament of breakthrough pain.
oral fentanyl
NO INTERVENTION50 patients with Breakthrough pain will receive sublingual fentanyl for treament of breakthrough pain.
Interventions
Eligibility Criteria
You may qualify if:
- Eligible participants were all:
- adults aged 18 or over
- suffering from Background pain cancer pain
- whose cancer pain was treated with strong opioids and
- who had breakthrough pain which met the criteria described by Portenoy.
You may not qualify if:
- less than18 years old,
- non-controlled basal pain,
- hospitalized patients, or cognitive disturbances,
- patients with contraindication to NSAIDS such as:
- gastric ulcer,
- impaired renal function,
- cerebrovascular accident,
- coronary artery bypass graft,
- uncontrolled hypertension,
- patients with coagulation anomalies such as hepatic disease or
- patients a previous history of allergy to NSAID.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ayman A Yousef
Assistant professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
March 3, 2015
First Posted
March 9, 2015
Study Start
December 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
May 13, 2016
Record last verified: 2016-05