A randomized double-blind, placebo-controlled, parallel group clinical study of pregabalin in patients with chronic pancreatitis

Phase 4

Completed

Conditions: chronic inflammation of the pancreas
Chronic pancreatitis
10017969

Registration Number: NL-OMON33997

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. Male or female patients between the ages of 18 and 70 years with a diagnosis of chronic pancreatitis, diagnosed using the Marseille-Rome/Cambridge diagnostic criteria. Both diabetic and non-diabetic patients will be allowed to enter the study.
2. 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.
3. Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
4. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.

Exclusion Criteria

1. Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
2. Presence or history of major depression.
3. 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.
4. 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.
5. 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.
6. Patients treated with pregabalin (Lyrica®) during the previous 4 months.
7. Treatment with an investigational drug within 4 months preceding the first dose of study medication of importance for this study as judged by investigator.
8. 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.
9. Patients unwilling or unable to comply with the lifestyle guidelines.
10. Patients must not suffer from painful conditions other than chronic pancreatitis.
11. Clinical significant illness within two weeks of participating in this study.
12. Involved in planning or conducting the study.
13. Hypersensitivity to pregabalin or any of its components.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy parameter to be evaluated is pain relief. In the clinical<br /><br>part of the study the effect is assessed as changes in the daily experience of<br /><br>pain, which will be assessed using questionnaires, including the modified brief<br /><br>pain inventory-short form (mBPI-sf), the painDETECT questionnaire and patient<br /><br>global impression of change.<br /><br>In the experimental part the analgesic effect is assessed as changes in the<br /><br>experimental endpoints (i.e. QST parameters). All changes are compared to<br /><br>baseline recordings. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary efficacy parameters are changes in quality of life compared to<br /><br>baseline level. The European Organization for research and treatment of cancer<br /><br>quality of life questionnaire, will be used. Also the tolerability of the drug<br /><br>in this patient population will be compared to placebo.<br /><br>In the experimental part of the study the slope of the QST stimulus response<br /><br>curves are considered secondary efficacy parameters. The experimental baseline<br /><br>recordings will also be compared to recordings from healthy controls to<br /><br>evaluate general aspects of pain processing in the patient group.</p><br>