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Gastric EmptyingPhase 1NCT00896246

Scintigraphic Assessment Following Klean-Prep® or Moviprep®

A Phase 1 study testing Klean-Prep® and Moviprep® in people with Gastric Emptying and Healthy, run by Norgine 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
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Trial summary

This was a phase 1, open-label, randomized study, designed to assess the impact of Moviprep® or Klean-Prep® on gastrointestinal transit. It was performed in two parallel groups with Part A in two groups of four subjects preceding Part B, which was performed in two groups of 12 subjects. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Gastric Emptying, Healthy
What is being tested?
Klean-Prep® and Moviprep®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2006to Nov 2006
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 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy males;
  • Aged 18-65 years;
  • Body Mass Index of 18-35 kg/m2;
  • Must be willing and able to participate in the whole study and must provide written informed consent.

Who cannot join

  • Participation in a clinical research study involving investigational drugs or dosage forms within the previous 3 months;
  • Subjects who have previously been enrolled in this study;
  • Subjects who have ever sought advice from or been referred to a GP or counsellor for abuse or misuse of alcohol, non medical drugs, medicinal drugs or other substance abuse e.g. solvents;
  • Subjects who admit to any current or previous use of Class A drugs such as opiates, cocaine, ecstasy, LSD (d lysergic acid diethylamide) and intravenous amphetamines. Subjects who admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs of abuse test and have abstained from cannabis use for at least 3 months;
  • Positive drugs of abuse test result;
  • Regular alcohol consumption > 21 units per week (1 Unit = ½ pint beer, a 25 mL shot of 40% spirit or a 125 mL glass of wine);
Show all 18Show fewer
  • Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening;
  • Radiation exposure from clinical trials, including that from the present study and from diagnostic x rays but excluding background radiation, exceeding 5 mSv in the last twelve months or 10 mSv in the last five years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study;
  • Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the PMI;
  • History of gastrointestinal surgery (with the exception of appendectomy unless it was performed within the previous 12 months);
  • History of clinically significant cardiovascular, renal, hepatic, respiratory and particularly gastrointestinal disease, especially peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease or Irritable Bowel Syndrome;
  • Subjects with a hypersensitivity to any of the ingredients in either Moviprep® or Klean- Prep®;
  • Diarrhoea or constipation in the 7 days before the predicted first study day. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than three times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day.
  • Subjects will be excluded from the study if they are considered by the PMI to be at risk of transmitting, through blood or other body fluids, the agents responsible for AIDS (Acquired Immunodeficiency Syndrome), other sexually transmitted disease or hepatitis. This will be assessed by the use of a question which requires that a potential subject decides whether he fulfills any category included on a reference card. If the answer is 'yes', the subject is excluded from the study;
  • Positive HBV, HCV or HIV results;
  • Subjects receiving prohibited medication as described in Section 7.4. Subjects must not stop taking a prescribed medication for the purpose of entering the study;
  • Subjects with a history of phenylketonuria or glucose-6-phosphate dehydrogenase deficiency;
  • Failure to satisfy the PMI of fitness to participate for any other reason.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Pharmaceutical Profiles Ltd

    Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: Scintigraphic Assessment of Gastrointestinal Transit Following Administration of Klean-Prep® (4L) or Moviprep® (2L) to Healthy Volunteers.

This was a phase 1, open-label, randomized study, designed to assess the impact of Moviprep® or Klean-Prep® on gastrointestinal transit. It was performed in two parallel groups with Part A in two groups of four subjects preceding Part B, which was performed in two groups of 12 subjects. Subjects attended a pre-study medical within 28 days of dosing and a post-study medical 5-10 days after the final dose. Within both Part A and Part B, subjects were required to attend the clinical unit for 2 study periods. Part A consisted of a baseline period to determine individual reference times for gastrointestinal transit. Part B was the test period in which gastrointestinal transit following the administration of the test preparations was assessed.

Being tested
Klean-Prep®, Moviprep®

What participants receive

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

  • Klean-Prep®Drug

    Four litres of solution administered orally as a divided dose.

  • Moviprep®Drug

    Two litres of solution administered orally as a divided dose

Study groups in NCT00896246
Study groupRoleWhat they receive
Klean-Prep®Active comparator1 x gelatin capsule containing not more than 1 MBq 111In radiolabelled ion exchange resin plus Klean-Prep® (4 L) containing 99mTc-DTPA administered as a divided dose.
Receives: Drug: Klean-Prep®
Moviprep®Experimental1 x gelatin capsule containing not more than 1 MBq 111In radiolabelled ion exchange resin plus Moviprep® (2 L) containing radiolabelled 99mTc-DTPA administered as a divided dose.
Receives: Drug: Moviprep®

What is being measured

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

  1. To assess the impact of Moviprep® and Klean-Prep® on time of colonic transit of the contents of the colon in comparison to baseline

    Measured: 2-4 days

Secondary outcomes (3)

  1. To assess the gastrointestinal transit of Moviprep® and Klean-Prep® in comparison to baseline

    Measured: 2-4 days

  2. To determine gastric emptying of Moviprep® and Klean-Prep®

    Measured: 2-4 days

  3. To collect information about stool weight, visual characteristics and distribution of the radiolabel

    Measured: 2-4 days

Timeline

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

  1. First posted11 May 2009 (estimated)
  2. Study startSep 2006
  3. Primary completionOct 2006
  4. Study completionNov 2006

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00896246
Sponsor's protocol ID
NRL994-01/2007 (GLO)
Status last verified
May 2009
First submitted
8 May 2009
Last updated
12 May 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Klean-Prep® and Moviprep® in people with Gastric Emptying and Healthy, run by Norgine 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 4 inclusion and 18 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 12 May 2009. 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?

To assess the impact of Moviprep® and Klean-Prep® on time of colonic transit of the contents of the colon in comparison to baseline (time frame: 2-4 days). 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 NCT00896246.

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 12 May 2009.

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