Pain and Chronic Pancreatitis - Clinical End Experimental Studies

NCT00755573 | Completed Phase 2 DMC

• 1 other identifier: A0081172/8967
• Study Type: interventional
• Target: 64
• Locations: 2 countries
• Sites: 2

Brief Summary

The aim of the study is to investigate the effect of pregabalin in pain resulting from chronic pancreatitis. The effect will be investigated by means of questionnaires concerning the daily experience of pain and the general quality of life. Furthermore the patients will be invited to participate in experimental testing with a multimodal pain model. The experimental testing will include stimulation of the skin, muscle and visceral tissue. The results from the experimental part of the study may help us to understand the mechanisms of action of pregabalin in this patient population.

Conditions

Chronic Pancreatitis

Keywords

Pain; Neuropathic pain

Outcome Measures

Primary Outcomes (1)

• Patient pain diary based on the VAS score and different questionaries

  The primary efficacy parameter to be evaluated is pain relief assessed using a patient pain diary based on the visual analog scale (VAS). Furthermore different questionnaires, including the modified brief pain inventory-short form (mBPI-sf), the painDETECT questionnaire (PD-Q) and patient global impression of change (PGIC)will be used to explore further aspects of pain character and influence on cognitive and affective components.

  Pain diary treatmentday -7 to +21. Questionaries are adressed 7 days prior to study medication and on day 21 during the study medication period

Secondary Outcomes (1)

• Questionary addressing quality of life

  Questionaries are adressed 7 days prior to study medication and on day 21 during the study medication period

Study Arms (2)

Pregabalin

ACTIVE COMPARATOR

Pregabalin 300 mg - 600 mg BID

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

Placebo arm

Drug: placebo

Interventions

Pregabalin DRUG

Pregabalin 300 mg - 600 mg BID

Also known as: Lyrica

Pregabalin

placebo DRUG

Regime as described for pregabalin

Also known as: Inactive comparator (placebo)

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients between the ages of 18 and 75 years with a diagnosis of chronic pancreatitis diagnosed using the Mayo Clinic Diagnostic criteria criteria ((Layer P, Gastroenterology 1994;107:1481-1487\]). Both diabetic and non-diabetic patients will be allowed to enter the study.
• The patients must suffer from chronic abdominal pain typical for pancreatitis, meet the criteria for chronic pain (pain ≥ 3 days per week in at least 3 months) and must consider their pain as severe enough for medical treatment.
• Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
• Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.

You may not qualify if:

• Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator
• Presence or history of major depression
• Patients with previously diagnosed moderate to severe renal impairment. Patients with creatinine values \> 2x ULN and/or with a significant change to their normal values should be excluded.
• Patients with a screening 12-lead ECG demonstrating any of the following: heart rate \>100 bpm, QRS duration \>120 msec, QTc interval \>450 msec, PR interval \>210 msec, any clinically significant rhythm abnormality, any evidence of myocardial ischemia or injury.
• Patients with any clinically significant laboratory abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
• Patients treated with pregabalin (Lyrica®) during the previous 4 months.
• Treatment with an investigational drug within 4 months preceding the first dose of study medication of importance for this study as judged by investigator.
• Female patients who are pregnant or lactating, or intend to become pregnant. Male patients who intend to father a child during the course of the study. A pregnancy test will be conducted at visit 1 and 3 to ensure that female patients are not pregnant during the study period. The investigator will have to ensure that fertile female patients use a safe contraception method during the study and for at least 35 hours after termination of the study period. The following methods are considered as safe contraception methods:
• The pill
• IUD
• Gestagen Injection
• Subdermal Implantation (Implanon)
• Hormone vaginal ring
• Transdermal Plaster
• Patients unwilling or unable to comply with the lifestyle guidelines.

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Radboud University Medical Center: collaborator

Study Sites (2)

Department of Gastroenterology, Aalborg Hospital

Aalborg, 9000, Denmark

Location

Department of Suregery, Radboud University Nijmegen Medical Centre

Nijmegen, 6500, Netherlands

Location

Related Publications (2)

• Bouwense SA, Olesen SS, Drewes AM, Poley JW, van Goor H, Wilder-Smith OH. Effects of pregabalin on central sensitization in patients with chronic pancreatitis in a randomized, controlled trial. PLoS One. 2012;7(8):e42096. doi: 10.1371/journal.pone.0042096. Epub 2012 Aug 6.

  PMID: 22879908 DERIVED

• Olesen SS, Graversen C, Olesen AE, Frokjaer JB, Wilder-Smith O, van Goor H, Valeriani M, Drewes AM. Randomised clinical trial: pregabalin attenuates experimental visceral pain through sub-cortical mechanisms in patients with painful chronic pancreatitis. Aliment Pharmacol Ther. 2011 Oct;34(8):878-87. doi: 10.1111/j.1365-2036.2011.04802.x. Epub 2011 Aug 16.

  PMID: 21848870 DERIVED

MeSH Terms

Conditions

Pancreatitis, Chronic; Pain; Neuralgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Asbjørn M Drewes, MD, PhD

  Dapartment og Gastroenterology, Aalborg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 18, 2008
• First Posted: September 19, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 20, 2010

Record last verified: 2009-07

Locations

DK (1); NL (1)