A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP CLINICAL AND EXPERIMENTAL PILOTSTUDY OF PREGABALIN IN PATIENTS WITH CHRONIC PANCREATITIS

• Register: EUCTR
• Last refreshed on: 17 October 2016
• Main ID: EUCTR2008-002671-27-DK
• Date of registration: 30/05/2008
• Prospective Registration: Yes
• Primary sponsor: Department of Medical Gastroenterology
• Public title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP CLINICAL AND EXPERIMENTAL PILOTSTUDY OF PREGABALIN IN PATIENTS WITH CHRONIC PANCREATITIS
• Scientific title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP CLINICAL AND EXPERIMENTAL PILOTSTUDY OF PREGABALIN IN PATIENTS WITH CHRONIC PANCREATITIS
• Date of first enrolment: 14/07/2008
• Target sample size: 45
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002671-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Denmark

Key inclusion & exclusion criteria

Inclusion criteria:
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 (Etemad and Whitcomb, 2001 [24]). 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 Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
4 Patients who are willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic pancreatitis
MedDRA version: 9.1 Level: LLT Classification code 10033649 Term: Pancreatitis chronic

Intervention(s)

Trade Name: Lyrica
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: pregabalin
CAS Number: 148553508
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
INN or Proposed INN: Pregabalin
CAS Number: 148553508
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: In the clinical part of the study a secondary objective is to understand the effect of pregabalin on the quality of life of patients with chronic pancreatitis. Further secondary objectives are to understand the safety, tolerability and absorption of pregabalin in this patient population.

Primary end point(s): The primary efficacy parameter to be evaluated is pain relief. In the clinical part of the study the effect is assessed as changes in the daily experience of pain, which will be assessed using questionnaires, including the modified brief pain inventory-short form (mBPI-sf), the painDETECT questionnaire (PD-Q, Freynhagen et al. 2006) and patient global impression of change (PGIC, Farrar et al. 2001). In the experimental part the analgesic effect is assessed as changes in the experimental endpoints. All changes are compared to baseline recordings.

Main Objective: The present study consists of two parts: one clinical and one experimental. In the clinical part the aim is to investigate the effect of pregabalin on clinical pain resulting from chronic pancreatitis. In the clinical part of the study, the primary objective is to understand the effect of pregabalin on the daily pain experienced by patients with chronic pancreatitis.
The experimental part aims at evaluating the effect of pregabalin in controlled and standardized circumstances. In the experimental part of the study the primary objective is to understand the effect of pregabalin on the intensity of pain evoked by the experimental procedures in patients with chronic pancreatitis.

Secondary ID(s)

28.04.2008