Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00192

2 Trial Registration Date

2009-08-13

i Registration Status

Prospective

3 Secondary IDs

NIl

4 Source(s) of Funding

Department of Anaesthesia and Intensive Care, CUHK

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr Tsang Ho Sze

ii Address

Department of Anaesthesia and Intensive Care, CUHK

iii Phone

26322735

iv Email

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr Tsang Ho Sze

ii Address

Department of Anaesthesia and Intensive Care, CUHK

iii Phone

26322735

iv Email

v Affiliation

vi Country

9 Official Scientific Title of the Study

Efficacy of TTS-fentanyl given after weak opioid in patients with cancer related pain without stabilization phase: An open label study

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Efficacy of TTS-fentanyl in cancer related pain

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2009-07-23

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Cancer pain

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Fentanyl Transdermal patch

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

28 days

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Oral morphine

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion Criteria
Patients who meet the following criteria will be enrolled:
With pain secondary to cancer.
Must have a histologically confirmed malignancy that has either recurred after potentially curative therapy or is not amenable to curative therapy at presentation.
Must have pain caused by the presence of malignant disease;
Must require analgesic according to Step III of the WHO analgesic ladder;
Have cancer-related pain with average 24hour pain score > 4;
Aged ≥ 18 years;
Estimated life expectancy of at least 3 months;
Ability to communicate effectively with the study personnel about the nature of their pain and be able to complete their diary;
Ability to read and sign informed consent;
Women of childbearing age must take adequate contraception;

ii Exclusion Criteria

Exclusion Criteria
A patient will be excluded from the study if he/she has any of the following:
A history of opioid allergy;
A history of narcotic abuse prior to the diagnosis of cancer;
Active skin disease that precludes the use of transdermal patches;
Clinically relevant CO2 retention (e.g. COPD);
Abnormal laboratory values*:
Serum bilirubin level > 34 μmol/L (>2.0 mg/ dL)
Serum creatine > 177 μmol/L (> 2.0 mg/dL)
Any co-existing neuropathic pain;
Receiving regular treatment with an strong opioid for their pain before entering the study,
Received radiation therapy or changes in hormonal and/or chemotherapy within 7 days prior to study entry;
Participated in an investigational drug trial 30 days prior to the selection;
Any co-existing medical condition that is likely to interfere with the study process;
Palliative Performance Scale (PPS) of less than 70.

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Dose comparison

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2009-09-01

21 Target Sample Size

72

22 Recruitment Status

Unknown

23 Primary Outcome

Primary Parameters:
The primary parameters are:
The dose of TTS-fentanyl:
The investigator will record the dose of TTS-fentanyl used by the patient and the date of change.

Pain Score Assessment:
The severity of pain will be evaluated by average pain score in 24 hours using Numerical Rating Scale (NRS). The patient will complete his/her diary daily.

Overall Satisfaction in Pain Control:
The patient will make a global assessment of his/her pain treatment using a 4-point scale (excellent, good, fair, poor) at the start of the study (visit 2), visit 3 and at the end of the study (day 28, visit 4) with investigator.

24 Secondary Outcome

Secondary Parameters:
Nausea, Vomiting and Sedation:
The severity will be evaluated using a 4-point scale: absent, mild, moderate, severe and recorded in the patient’s diary. The frequency of vomiting and his concomitant medication will be recorded on the diary. It will also be evaluated by investigator at each study visits.

Gastrointestinal disturbances
The investigator will assess the effects on the gastrointestinal track by evaluating the number, the consistency and the passage of stools, the presence of abdominal pain and bloating and the use of laxatives at each visit.

Evaluation of the use of the patches.
The patient will be asked to rate the convenience of the patches on a 4-point scale (excellent, good, fair, poor) at visit 3 and 4. The patient must be instructed to report any early removal of patch (<3days) immediately to the investigator. An overall evaluation on patient’s preference will also be made at visit 4 or end of the trial.

General condition.
The investigator will record the patients’ general condition using the Palliative Performance Scale at the start of the study (visit 2) and further at all study visits.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-04-18

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000742

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

nil

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Trial History Detail on 2012-08-31