AzTrials
AzTrials

PainPhase 1NCT02714842

Delayed Release Diclofenac Sodium Formulation vs Voltaren®

A Phase 1 study testing Radiolabelled Diclofenac Tablet A, Radiolabelled Diclofenac tablet B and Radiolabelled Diclofenac tablet C in people with Pain, run by BDD Pharma Ltd at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a single-centre, open-label, randomised, three-arm crossover study with a fourth fixed arm in a subset of subjects. Up to 36 healthy male volunteers will participate in the study. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
Radiolabelled Diclofenac Tablet A, Radiolabelled Diclofenac tablet B and Radiolabelled Diclofenac tablet C
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2016to May 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male
  • Aged between 18 and 55 years inclusive.
  • Weight \& Body mass index (BMI)
  • BMI between 18.0 and 29.9 kg/m², inclusive. Body weight ≥50 kg
  • Understands and is willing, able and likely to comply with all study procedures and restrictions.
  • Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent (signed and dated) obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
  • Good general health with (in the opinion of the Investigator) no clinically significant and relevant abnormalities of medical history or physical examination.

Who cannot join

  • Current or relevant previous history of severe or uncontrolled disease that, in the opinion of the physician responsible, could affect the study conduct or laboratory assessments (e.g., renal, cardiovascular, hepatic, hematologic, endocrine, pulmonary, psychiatric, neurologic, or cerebral disease).
  • Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
  • A history of current or relevant previous non self-limiting gastrointestinal disorders in particular, peptic ulcer disease and/or gastrointestinal bleeding.
  • A history of hypersensitivity to aspirin or any other NSAID.
  • Suffering from asthma requiring current treatment.
  • Currently suffering from disease known to impact gastric emptying, e.g., migraine, insulin-dependent diabetes mellitus.
Show all 32Show fewer
  • Laboratory screening results that suggest an abnormal liver and/or renal function.
  • Subject has a screening QTc value of greater than or equal to 450 msec or an ECG that is not suitable for QTc measurements (e.g., poorly defined termination of the T-wave). The ECG taken at screening must be considered not clinically significant by the Investigator/ study physician.
  • Currently suffering from bleeding or coagulation disorders.
  • As a result of a physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study.
  • Subject has taken prescribed medication within 14 days prior to the first assessment visit which, in the opinion of the physician responsible, will interfere with the study procedures or compromise safety. Subjects will be withdrawn from subsequent study days if they commence taking prescribed medication during the study period which, in the opinion of the physician responsible, will interfere with the study procedures or compromise safety.
  • Subject has taken over-the-counter (OTC) medication within 48 hours prior to each assessment visit. T This includes the use of vitamins and natural or herbal remedies e.g., St John's Wort. Subjects who have taken OTC medication may still be entered into the study if, in the opinion of the physician responsible, the medication will not interfere with the study procedures or compromise safety. The occasional use of paracetamol for pain relief (within its labelled dosage) is permitted but must not be taken within 48 hours of an Assessment Visit.
  • Recent history (within the last year) of alcohol or other substance abuse.
  • Subject has an average weekly alcohol intake of greater than 21 units. 1 unit is equivalent to one 25 mL single measure of whisky, or a third of a pint of beer or half a standard (175 mL) glass of red wine.
  • Subject has positive urine drugs of abuse test at screening. Note: At the discretion of the Investigator, the test may be repeated.
  • Subject has a positive breath alcohol test at screening.
  • Subject has recently discontinued smoking (less than 3 months).
  • Subject is currently a smoker or user of nicotine-containing products.
  • Subject has a history of allergy to the study drug diclofenac sodium, to any component of the dosage form or any other allergy, which, in the opinion of the physician responsible, contraindicates their participation.
  • Has an allergy to any of the contents of the meals.
  • Subject is vegetarian.
  • Subject claims to be lactose intolerant.
  • Participation in another clinical study (inclusive of final post-study examination) or receipt of an investigational drug within the 12 weeks before screening visit.
  • Previous participation in this study.
  • Subject whose participation in this study will result in a participation in more than four studies over a twelve month period.
  • An employee of the sponsor, client or study site or members of their immediate family.
  • Subjects for whom participation in this study will exceed the limits of total radiation exposure allowed in any 12 month period (5 mSv), or will exceed 10 mSv over any three year period.
  • Subjects who are intending to father a child in the 3 months following the study or are unwilling to abstain from sexual intercourse with pregnant or lactating women.
  • Subjects who are unwilling to use a condom/spermicide in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of the first assessment visit until 3 months following the study.
  • Subject has donated blood or experienced significant blood loss within 3 months of screening and throughout the duration of the study.
  • Difficulty accessing forearm veins for cannulation or blood sampling.
  • Subject has any non-removable metal objects such as metal plates, screws etc. in their chest or abdominal area.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Bio Images Research Ltd

    Glasgow, G4 0SF

Other trials in United Kingdom

About this study

Official title: A Pharmacoscintigraphic Clinical Study to Investigate the in Vivo Behaviour of a Novel Delayed-release Formulation of Diclofenac in Comparison to the Voltaren® Enteric Coated Tablet Commercial Formulation in Healthy Volunteers

This is a single-centre, open-label, randomised, three-arm crossover study with a fourth fixed arm in a subset of subjects. Up to 36 healthy male volunteers will participate in the study. This study is designed to correlate the gastrointestinal transit behaviour of delayed-release diclofenac sodium tablets with their pharmacokinetic (PK) absorption profiles.

The investigators will be looking at:

  1. The behaviour of the tablets (when, where and how quickly they break up)
  2. The gastric emptying time of the tablets (when they leave the stomach)
  3. The gastrointestinal transit of the tablets (how long they take to travel through the gut)
  4. Blood levels of the drug (diclofenac)
Conditions
Pain
Being tested
Radiolabelled Diclofenac Tablet A, Radiolabelled Diclofenac tablet B, Radiolabelled Diclofenac tablet C, Diclofenac
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiolabelled Diclofenac Tablet ADrug

    Also called Delayed release diclofenac sodium tablet

    Delayed release diclofenac sodium tablet (50 mg)

  • Radiolabelled Diclofenac tablet BDrug

    Also called Delayed release diclofenac sodium tablet

    Delayed release diclofenac sodium tablet (50 mg)

  • Radiolabelled Diclofenac tablet CDrug

    Also called Delayed release diclofenac sodium tablet

    Delayed release diclofenac sodium tablet (25 mg)

  • DiclofenacDrug

    Also called Voltaren

    Enteric coated delayed release diclofenac sodium tablet (50 mg)

Study groups in NCT02714842
Study groupRoleWhat they receive
Radiolabelled Diclofenac tablet AExperimentalSingle dose of delayed release diclofenac sodium (50 mg) tablet radiolabelled with 4 MBq 99mTc
Receives: Drug: Radiolabelled Diclofenac Tablet A
Radiolabelled diclofenac tablet BExperimentalSingle dose of delayed release diclofenac sodium (50 mg) tablet radiolabelled with 4 MBq 99mTc
Receives: Drug: Radiolabelled Diclofenac tablet B
VoltarenActive comparatorSingle dose of enteric coated diclofenac sodium (50 mg) tablet radiolabelled with 4 MBq 99mTc
Receives: Drug: Diclofenac
Radiolabelled diclofenac tablet CExperimentalSingle dose of delayed release diclofenac sodium (25 mg) tablet radiolabelled with 4 MBq 99mTc
Receives: Drug: Radiolabelled Diclofenac tablet C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gastrointestinal transit parameters - gastric emptying time, small intestinal transit time, and colon arrival time of radiolabel where applicable.

    Composite outcome

    Measured: 16 hours

Secondary outcomes (2)

  1. Scintigraphic analysis to determine the times and sites of onset and complete release of radiolabelled lactose.

    Composite outcome

    Measured: 16 hours

  2. Pharmacokinetic parameters plasma concentration (Cp) at each PK sampling point.

    Measured: 20 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02714842
Sponsor's protocol ID
FM1501
Status last verified
Sep 2016
First submitted
8 Mar 2016
Last updated
28 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Radiolabelled Diclofenac Tablet A, Radiolabelled Diclofenac tablet B and Radiolabelled Diclofenac tablet C in people with Pain, run by BDD Pharma Ltd at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gastrointestinal transit parameters - gastric emptying time, small intestinal transit time, and colon arrival time of radiolabel where applicable. (time frame: 16 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02714842.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT02714842 | AzTrials