?9-THC (Namisol®) in persistent postsurgical pai

Phase 1

• Conditions: Patients with persistent postsurgical abdominal pain; MedDRA version: 14.1Level: PTClassification code 10060932Term: Postoperative adhesionSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 14.1Level: PTClassification code 10000081Term: Abdominal painSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2012-000812-27-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-23
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

•Aged 18 years or older
•Postsurgical pain
•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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 68
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patient is diagnosed with irritated bowel syndrome (IBS) or chronic pancreatitis
•Patient has an indication for a pain treatment other then medication
•Patient took cannabinoids on a regular basisin past 3 years
•Patient does not feel a pinprick test in the lower extremities
•Patient has a body mass index (BMI) above 33,0 kg/m2
•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 an active hepatitis B, hepatitis C or HIV infection
•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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified