The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain

Chronic Pain Clinical Trial

Official title:

The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain; a Randomized, Double Blinded, Placebo-controlled, Experiment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562483
• Other study ID #: HEEL-2011-03
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2012
• Last updated: October 27, 2014
• Start date: October 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2014
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Chronic Pain
• Postsurgical Pain

Intervention

Drug:
• Tetrahydrocannabinol
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.
• Placebo
Identical to the Namisol arm.

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	European Union

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline versus day 52	No
Secondary	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).	Baseline versus day 52	No
Secondary	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).	Baseline versus day 15 and day 52	No
Secondary	Depression and (pain related) anxiety	Depression and (pain related) anxiety measured by questionnaires.	Baseline versus day 52	No
Secondary	Pharmacodynamic parameters	Pharmacodynamics measured by body sway and questionnaires (VASBond & Lader and VASBowdle)	Baseline versus day 15 and day 52	No
Secondary	Safety parameters	Laboratory; Electrocardiogram (ECG); Heart Frequency (HF) / Blood Pressure (BP); Adverse Events (AE)	Baseline until follow-up (day 59-61)	Yes
Secondary	Quality of life	Quality of life will be evaluated by questionnaires	Baseline versus day 52	No