Postsurgical PainPhase 2NCT01562483
The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain
A Phase 2 study testing Tetrahydrocannabinol in people with Postsurgical Pain and Abdominal Pain, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Persistent postsurgical abdominal pain (PPAP) is a very difficult to treat pain. This pain can persist for months or even years and significantly diminishes quality of life. The exact underlying cause for this pain persistence is still unclear, which makes its treatment still a challenge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postsurgical Pain, Abdominal Pain, Chronic Pain
- What is being tested?
- Tetrahydrocannabinol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2012to Jun 2014
- Phase
- Phase 2
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
- Pain should have developed after a surgical procedure
- 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
- Diagnosed irritated bowel syndrome (IBS) or chronic pancreatitis
- 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 36,0 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
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- Patient uses any kind of concomitant medication that may interfere with the study or may pose a risk for the patient
- 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
About this study
Official title: The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain; a Randomized, Double Blinded, Placebo-controlled, Experiment
Persistent postsurgical abdominal pain (PPAP) is a very difficult to treat pain. This pain can persist for months or even years and significantly diminishes quality of life. The exact underlying cause for this pain persistence is still unclear, which makes its treatment still a challenge. The promising analgesic effects of Δ9-THC in previous research, plus the improved bioavailability of Namisol® in comparison with previous Δ9-THC substances form the basis of the present research proposal.
The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic during a long-term treatment (52 days) of persistent postsurgical abdominal pain.
- Conditions
- Postsurgical Pain, Abdominal Pain, Chronic Pain
- Being tested
- Tetrahydrocannabinol, Placebo
- Keywords
- postsurgical pain, abdominal pain, visceral pain, chronic pain
- Medical subject headings
- Pain, Postoperative, 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 to the Namisol arm.
| Study group | Role | What they receive |
|---|---|---|
| delta-9-tetrahydrocannabinol (namisol) | Experimental | Not described Receives: Drug: Tetrahydrocannabinol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 pain diary.
Measured: Baseline versus day 52
Secondary outcomes (6)
Electroencephalogram (EEG)
Evoked potentials to noxious electrical stimuli, evoked potentials to auditory stimuli (oddball), and spontaneous brain activity will be measured in the electroencephalogram (EEG).
Measured: Baseline versus day 52
Quantitative Sensory Testing (QST)
Pressure pain thresholds, electrical thresholds, electric wind-up response, and Diffuse Noxious Inhibitory Control (DNIC) will be measured using Quantitative Sensory Testing (QST).
Measured: Baseline versus day 15 and day 52
Depression and (pain related) anxiety
Depression and (pain related) anxiety measured by questionnaires.
Measured: Baseline versus day 52
Pharmacodynamic parameters
Pharmacodynamics measured by body sway and questionnaires (VASBond \& Lader and VASBowdle)
Measured: Baseline versus day 15 and day 52
Safety parameters
- Laboratory
- Electrocardiogram (ECG)
- Heart Frequency (HF) / Blood Pressure (BP)
- Adverse Events (AE)
Measured: Baseline until follow-up (day 59-61)
Quality of life
Quality of life will be evaluated by questionnaires
Measured: Baseline versus day 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postsurgical PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
- Investigators
- Harry van Goor, MD, PhD, Principal investigator, Radboud University Nijmegen Medical Centre, department of surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562483
- Sponsor's protocol ID
- HEEL-2011-03
- Status last verified
- Oct 2014
- First submitted
- 7 Mar 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