AzTrials
AzTrials

Pancreatitis, ChronicPhase 2NCT01551511

Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain

A Phase 2 study testing Tetrahydrocannabinol in people with Pancreatitis, Chronic and Abdominal Pain, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Abdominal pain resulting from chronic pancreatitis (CP) is often recurrent, intense and long-lasting, and is extremely difficult to treat. Medical analgesic therapy is considered as first choice in pain management of CP, resulting in regularly prescription of opioids. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tetrahydrocannabinol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
29 participants
Where
1 siteNetherlands
Study dates
Oct 2012to Jun 2014
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 years or older
  • Confirmed chronic pancreatitis
  • Pain duration exceeding 3 months, and average NRS≥3
  • Stable doses intake of analgesics for the past 2 months
  • The patient has been informed about the study, understood the information and signed the informed consent form

Who cannot join

  • Patient took cannabinoids on a regular basis for at least one year
  • Patient does not feel a pinprick test in the lower extremities
  • Patient has a body mass index (BMI) above 32,0 kg/m2
  • Patient suffers from serious painful conditions other than chronic pancreatitis
  • Patient has a significant medical disorder that may interfere with the study or may pose a risk for the patient
  • Patient uses any kind of concomitant medication that may interfere with the study or may pose a risk for the patient
Show all 22Show fewer
  • Patient does not tolerate oral intake of medication or liquids, or is refrained from oral intake because of medical reasons
  • Patient demonstrates clinical relevant deviations in the electrocardiogram (ECG)
  • Patient has an actual moderate to severe renal impairment
  • Patient has an actual moderate to severe hepatic impairment
  • Patient has a presence or history of major psychiatric illness
  • Patient has experienced an epileptic seizure in the past
  • Patient demonstrates clinically significant laboratory abnormalities
  • Patient demonstrates a positive urine drug screen for THC, cocaine, MDMA, and amphetamines
  • Patient demonstrates a positive test result on hepatitis B surface antigen, hepatitis C antibody or HIV antibody test
  • Patient has a history of sensitivity / idiosyncrasy to THC
  • Patient has a known or suspected lactose intolerance
  • Female patient is pregnant or breastfeeding
  • Patient intends to conceive a child during the course of the study
  • Patient participates in another investigational drug study
  • Patient has a clinical significant exacerbation in illness
  • Patient is unwilling or unable to comply with the lifestyle guidelines

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboud University Nijmegen Medical Centre

    Nijmegen, 6500 HB

Other trials in Netherlands

About this study

Official title: Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain: a Randomized, Double-blinded, Placebo-controlled, Parallel Design

Abdominal pain resulting from chronic pancreatitis (CP) is often recurrent, intense and long-lasting, and is extremely difficult to treat. Medical analgesic therapy is considered as first choice in pain management of CP, resulting in regularly prescription of opioids. The adverse consequences of prolonged opioid use, including addiction, tolerance and opioid induced hyperalgesia, call for an alternative medical treatment. Cannabis has been used to treat pain for many centuries. Delta-9-tetrahydrocannabinol (Δ9-THC), the psychoactive substance of the cannabis plant, has been shown in previous studies to be a promising analgesic. The development of Namisol®, a tablet containing purified Δ9-THC showing an improved pharmacokinetic profile, provides the opportunity to test the analgesic potential of Δ9-THC in favourable conditions. The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic during a long-term treatment (52 days) of abdominal pain resulting from CP.

Being tested
Tetrahydrocannabinol, Placebo
Keywords
chronic pancreatitis, abdominal pain, visceral pain, chronic pain
Medical subject headings
Pancreatitis, Chronic, Abdominal Pain, Chronic Pain, Visceral Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TetrahydrocannabinolDrug

    Also called Namisol, Dronabinol

    The add-on treatment consists of two phases: a step-up phase (day 1-5: 3 mg TID; day 6-10: 5 mg TID), and a stable dose phase (day 11-52: 8 mg TID). The dosage may be tapered to at least 5 mg TID, when 8 mg is not tolerated.

  • PlaceboDrug

    Identical step-up approach to the Namisol arm.

Study groups in NCT01551511
Study groupRoleWhat they receive
delta-9-tetrahydrocannabinol (namisol)ExperimentalNot described
Receives: Drug: Tetrahydrocannabinol
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average VAS pain

    The primary outcome measure is defined as the reduction in average VAS pain scores at the end of the study (day 50-52) compared to the pre-treatment level between the Namisol® and placebo group, measured by a Visual Analoge Scale (VAS) in a daily pain diary.

    Measured: Baseline versus day 52

Secondary outcomes (7)

  1. EEG

    Electroencephalogram; measuring evoked potentials to noxious electrical stimuli, evoked potentials to auditory stimuli (oddball), and FFT of spontaneous EEG.

    Measured: Baseline and day 52

  2. QST

    Quantitative Sensory Testing; measuring pressure pain thresholds, electrical thresholds, electric wind-up response, and DNIC.

    Measured: Baseline versus day 15 and day 52

  3. Safety

    • Laboratory
    • ECG
    • HF / BP
    • Adverse events

    Measured: Baseline until follow-up (day 59-61)

  4. Pharmacokinetics

    THC, 11-OH-THC and THC-COOH concentrations

    Measured: Predose levels at baseline, day 15 and day 52; postdose levels (30 min, 45 min, 60 min, 100 min) at day 15 and 52

  5. Functional parameters

    • Body weight
    • Supplementary feeding

    Measured: Baseline until day 52

  6. Quality of life

    Quality of life will be evaluated by questionnaires

    Measured: Baseline versus day 52

  7. Pharmacodynamics

    Pharmacodynamics measured by body sway and questionnaires (VASBond \& Lader and VASBowdle)

    Measured: Baseline versus day 15 and day 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01551511
Sponsor's protocol ID
HEEL-2011-02
Status last verified
Oct 2014
First submitted
7 Feb 2012
Last updated
28 Oct 2014
Results posted
No
Data monitoring committee
No

Publications

  • de Vries M, van Rijckevorsel DCM, Vissers KCP, Wilder-Smith OHG, van Goor H; Pain and Nociception Neuroscience Research Group. Tetrahydrocannabinol Does Not Reduce Pain in Patients With Chronic Abdominal Pain in a Phase 2 Placebo-controlled Study. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1079-1086.e4. doi: 10.1016/j.cgh.2016.09.147. Epub 2016 Oct 5.

    PubMed 27720917

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tetrahydrocannabinol in people with Pancreatitis, Chronic and Abdominal Pain, run by Radboud University Medical Center at 1 site in Netherlands.

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 5 inclusion and 22 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: finished, as of the sponsor's last update on 28 Oct 2014. 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 Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Average VAS pain (time frame: Baseline versus day 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01551511, which also lists 1 linked publication.

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 28 Oct 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in