TIME 1 The First Therapeutic Intervention in Malignant Pleural Effusion Trial (TIME1) A 2 x 2 randomised factorial trial to assess whether non-steroidal anti-inflammatory analgesics and small bore chest tubes are less painful than opiate analgesics and large bore chest tubes in pleurodesis for malignant pleural effusion. - TIME 1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005226-31-GB

Enrollment

320

Registered

2005-12-12

Start date

2006-04-24

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant pleural effusion

Interventions

Product Name: Ibuprofen Pharmaceutical Form: Tablet INN or Proposed INN: Ibuprofen Concentration unit: mg milligram(s) Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by: a) Histologically proven pleural malignancy b) Typical features of pleural malignancy seen on direct vision during thoracoscopy c) Pleural effusion in the context of histologically proven cancer elsewhere 2. Written informed consent 3. Expected survival more than 1 month 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: Exclusion criteria: 1. Age < 18 years 2. Primary lymphoma or small cell lung carcinoma 3. Patients who are pregnant or lactating 4. Inability to give informed consent 5. History of gastrointestinal bleeding or of untreated peptic ulceration 6. Known sensitivity to Non-steroidal anti-inflammatory drugs (NSAIDs) / opiates 7. Hypercapnic respiratory failure 8. Known intravenous drug abuse 9. Severe renal or liver disease 10. Known bleeding diathesis 11. Warfarin therapy

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to establish whether non-steroidal anti-inflammatories (in the form of Ibuprofen) is more effective than opiate (in the form of morphine) in preventing post chemical pleurodesis pain (using sterile talc) in patients with maligant pleural effusion requiring pleurodesis, and whether large bore chest drains or small bore chest drains cause more pain during use for pleurodesis.; Secondary Objective: Secondary objective of the trial are: 1. To establish whether non-steroidal anti-inflammatories (in the form of Ibuprofen) is more effective than opiate (in the form of morphine) in preventing chronic chest pain post chemical pleurodesis pain (using sterile talc) in patients with maligant pleural effusion requiring pleurodesis 2. To establish whether analgesic type (i.e. ibuprofen or morphine) and chest drain size (i.e. large bore or small bore) influence the efficacy of pleurodesis at 3 months. ; Primary end point(s): Primary endpoint: The primary endpoint is average pain score over the 72 hour period post pleurodesis. This will be measured by a Visual Analogue Scale (VAS) of pain relief and pain intensity applied every 4 hourly during the day.	—

Measure

Time frame

Main Objective: The main objective of the trial is to establish whether non-steroidal anti-inflammatories (in the form of Ibuprofen) is more effective than opiate (in the form of morphine) in preventing post chemical pleurodesis pain (using sterile talc) in patients with maligant pleural effusion requiring pleurodesis, and whether large bore chest drains or small bore chest drains cause more pain during use for pleurodesis.; Secondary Objective: Secondary objective of the trial are: 1. To establish whether non-steroidal anti-inflammatories (in the form of Ibuprofen) is more effective than opiate (in the form of morphine) in preventing chronic chest pain post chemical pleurodesis pain (using sterile talc) in patients with maligant pleural effusion requiring pleurodesis 2. To establish whether analgesic type (i.e. ibuprofen or morphine) and chest drain size (i.e. large bore or small bore) influence the efficacy of pleurodesis at 3 months. ; Primary end point(s): Primary endpoint: The primary endpoint is average pain score over the 72 hour period post pleurodesis. This will be measured by a Visual Analogue Scale (VAS) of pain relief and pain intensity applied every 4 hourly during the day.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026