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

NCT01562483 | Completed Phase 2

• 1 other identifier: HEEL-2011-03
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postsurgical Pain; Abdominal Pain; Chronic Pain

Keywords

postsurgical pain; abdominal pain; visceral pain; chronic pain

Outcome Measures

Primary Outcomes (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 pain diary.

  Baseline versus day 52

Secondary Outcomes (6)

• Electroencephalogram (EEG)

  Baseline versus day 52

• Quantitative Sensory Testing (QST)

  Baseline versus day 15 and day 52

• Depression and (pain related) anxiety

  Baseline versus day 52

• Pharmacodynamic parameters

  Baseline versus day 15 and day 52

• Safety parameters

  Baseline until follow-up (day 59-61)

Study Arms (2)

delta-9-tetrahydrocannabinol (namisol)

EXPERIMENTAL

Drug: Tetrahydrocannabinol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tetrahydrocannabinol DRUG

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.

Also known as: Namisol, Dronabinol

delta-9-tetrahydrocannabinol (namisol)

Placebo DRUG

Identical to the Namisol arm.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• European Union: collaborator

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 27720917 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Abdominal Pain; Chronic Pain; Visceral Pain

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive; Nociceptive Pain

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Harry van Goor, MD, PhD

  Radboud University Nijmegen Medical Centre, department of surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 23, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

NL (1)