Pancreatic CancerPhase 4PANPAIN/1NCT01768988
Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study
A Phase 4 study testing Pregabalin in people with Pancreatic Cancer and Visceral Pain, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
This is a randomized, double blind controlled, parallel arms trial, aimed to assess the efficacy of pregabalin on pancreatic cancer induced abdominal pain. The goals of this study include (1) assessing the analgesic effect of pregabalin in comparison to placebo; assessing the presence of central sensitization and its… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pancreatic Cancer, Visceral Pain
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2012to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Patients > 18 years old recently diagnosed of pancreatic cancer (<3 months).
- 2. Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
- 3. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
Who cannot join
- 1. Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- 2. Patients with previously diagnosed moderate to severe renal impairment. Those with a Clearance of Creatinine (CLcr) < 60mL/min should be excluded.
- 3. Patients treated with anticonvulsants during the previous 4 months.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, double blind controlled, parallel arms trial, aimed to assess the efficacy of pregabalin on pancreatic cancer induced abdominal pain. The goals of this study include (1) assessing the analgesic effect of pregabalin in comparison to placebo; assessing the presence of central sensitization and its potential reversion by Pregabalin; (3) assessing quality of life of patients treated with pregabalin in comparison to placebo; (4) to compare adverse effects in patients treated with Pregabalin in comparison to placebo; (5) to compare anxiety and depression in patients treated with pregabalin in comparison to placebo.
- Conditions
- Pancreatic Cancer, Visceral Pain
- Being tested
- Placebo, Pregabalin
- Medical subject headings
- Pancreatic Neoplasms, Visceral Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Conventional treatment + placebo (during 90 days).
Conventional treatment comprises a WHO step ladder approach and comprises in most cases:
- Paracetamol 1g/8h
- Weak opioid (tramadol at maximal doses of 400 mg/24h)
- Strong opioid in substitution of weak opioid if not efficient (e. g. morphine, oxycodone, fentanyl patch, hidromorphone), at the needed doses to control pain (VAS < 3).
PregabalinDrug
Treatment during 90 days with conventional treatment + pregabalin.
Pregabalin doses were reached until the maximal doses (300 mg/12h) depending on patient tolerability. An escalating dose scheme were desigened as follows, to avoid tolerability problems:
Week 1 75-0-75 Week 2 75-0-150 Week 3 150-0-150 Week 4 150-0-300 Week 5 300-0-300 (until the end of study)
Conventional treatment comprises a WHO step ladder approach and comprises in most cases:
- Paracetamol 1g/8h
- Weak opioid (tramadol at maximal doses of 400 mg/24h)
- Strong opioid in substitution of weak opioid if not efficient (e. g. morphine, oxycodone, fentanyl patch, hidromorphone), at the needed doses to control pain (VAS < 3).
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Conventional analgesic treatment + pregabalin. Receives: Drug: Pregabalin |
| Group II | Placebo comparator | Conventional analgesic treatment + placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (Visual Analogue Scale; VAS Score)
Analgesic effect of pregabalin therapy in pancreatic cancer patients, assessed using a visual analogue scale (VAS), the Brief Pain Inventory (BPI) and Neuropathic Pain VAS score.
Measured: From baseline to day 90.
Secondary outcomes (4)
Quality of life
Changes in quality of life compared to baseline level using SF-36 (Short-Form Health Survey) quality of life questionnaire.
Measured: From baseline to day 90.
Performance status
Performance status (Karnofsky Performance Status Scale).
Measured: From baseline until to day 90.
Anxiety and depression
Anxiety and depression will be also assessed, using Hospital Anxiety and Depression Scale (HADS).
Measured: From baseline to day 90.
Neuropathic Pain
Neuropathic pain participation will be measured by a neuropathic pain questionnaire (NPSI).
Measured: From baseline to day 90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startAug 2012
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Change of PI. Former PI changed from Research Center and Promoter obliged unexpectedly to change the PI.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CDursteler, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768988
- Sponsor's protocol ID
- PANPAIN/1
- Acronym
- PANPAIN/1
- Status last verified
- Oct 2017
- First submitted
- 14 Jan 2013
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study
- ClinicalTrials.gov ID
- NCT01768988
- Acronym / sponsor ID
- PANPAIN/1 / PANPAIN/1
- Conditions
- Pancreatic Cancer, Visceral Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change of PI. Former PI changed from Research Center and Promoter obliged unexpectedly to change the PI.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double blind controlled, parallel arms trial, aimed to assess the efficacy of pregabalin on pancreatic cancer induced abdominal pain. The goals of this study include (1) assessing the analgesic effect of pregabalin in comparison to placebo; assessing the presence of central sensitization and its potential reversion by Pregabalin; (3) assessing quality of life of patients treated with pregabalin in comparison to placebo; (4) to compare adverse effects in patients treated with Pregabalin in comparison to placebo; (5) to compare anxiety and depression in patients treated with pregabalin in comparison to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: PregabalinConventional analgesic treatment + pregabalin. |
| Group II | Placebo comparator | Drug: PlaceboConventional analgesic treatment + placebo. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1. Patients > 18 years old recently diagnosed of pancreatic cancer (<3 months).
- 2. Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
- 3. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
Key exclusion criteria (3 listed)
- 1. Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- 2. Patients with previously diagnosed moderate to severe renal impairment. Those with a Clearance of Creatinine (CLcr) < 60mL/min should be excluded.
- 3. Patients treated with anticonvulsants during the previous 4 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboConventional treatment + placebo (during 90 days). Conventional treatment comprises a WHO step ladder approach and comprises in most cases: 1. Paracetamol 1g/8h 2. Weak opioid (tramadol at maximal doses of 400 mg/24h) 3. Strong opioid in substitution of weak opioid if not efficient (e. g. morphine, oxycodone, fentanyl patch, hidromorphone), at the needed doses to control pain (VAS < 3). | Drug | Group II |
| PregabalinTreatment during 90 days with conventional treatment + pregabalin. Pregabalin doses were reached until the maximal doses (300 mg/12h) depending on patient tolerability. An escalating dose scheme were desigened as follows, to avoid tolerability problems: Week 1 75-0-75 Week 2 75-0-150 Week 3 150-0-150 Week 4 150-0-300 Week 5 300-0-300 (until the end of study) Conventional treatment comprises a WHO step ladder approach and comprises in most cases: 1. Paracetamol 1g/8h 2. Weak opioid (tramadol at maximal doses of 400 mg/24h) 3. Strong opioid in substitution of weak opioid if not efficient (e. g. morphine, oxycodone, fentanyl patch, hidromorphone), at the needed doses to control pain (VAS < 3). | Drug | Group I |
Primary outcome
Pain intensity (Visual Analogue Scale; VAS Score)
Time frame: From baseline to day 90.
Analgesic effect of pregabalin therapy in pancreatic cancer patients, assessed using a visual analogue scale (VAS), the Brief Pain Inventory (BPI) and Neuropathic Pain VAS score.
4 secondary outcomes
Quality of life
Time frame: From baseline to day 90.
Performance status
Time frame: From baseline until to day 90.
Anxiety and depression
Time frame: From baseline to day 90.
Neuropathic Pain
Time frame: From baseline to day 90.
Results and safety
The study was stopped early (reason given: Change of PI. Former PI changed from Research Center and Promoter obliged unexpectedly to change the PI.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin in people with Pancreatic Cancer and Visceral Pain, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Change of PI. Former PI changed from Research Center and Promoter obliged unexpectedly to change the PI.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (Visual Analogue Scale; VAS Score) (time frame: From baseline to day 90.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.